计划状态
活跃，非招募阶段
第三阶段允许先接受免疫治疗
没有CRC 指导的试验
是药物
Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody, Regorafenib, XL092, Stivarga, Tecentriq标签
MSS/ MMRp评论
Phase III trial (STELLAR-003), only for MSS CRC patients.
Immunotherapy combination vs standard of care (SOC).
Immunotherapy arm: XL092 (tyrosine kinase inhibitor (TKI)) in combination with atezolizumab (anti PD-L1, checkpoint inhibitor, immunotherapy)
Standard of care arm: regorafenib (Stivarga)
Key inclusion criteria: no prior Stivarga, Lonsurf, or anti PD-L1/PD-1 immunotherapies.
Measurable disease.
Prior trials of the TKI XL092 (alone or in combinations) (STELLAR-001, STELLAR-002) show that is active and safe. Prior trials of other TKI (cabozantinib) plus immunotherapies (COSMIC-021, CAMILLA) showed meaningful activity in mCRC.
查看有用链接
| 地点 | 位置状态 |
|---|---|
| 美国 | |
|
Exelixis Clinical Site #65 Jonesboro, Alabama 72401 |
活跃，非招募 |
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Exelixis Clinical Site #30 Phoenix, Arizona 85004 |
活跃，非招募 |
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Exelixis Clinical Site #70 Tucson, Arizona 85719 |
活跃，非招募 |
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Exelixis Clinical Site #9 加利福尼亚州杜阿尔特 91010 |
活跃，非招募 |
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Exelixis Clinical Site #55 La Jolla, California 92037 |
活跃，非招募 |
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Exelixis Clinical Site #77 加利福尼亚州洛杉矶 90095 |
活跃，非招募 |
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Exelixis Clinical Site #105 加利福尼亚州奥兰治 92868 |
活跃，非招募 |
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Exelixis Clinical Site #80 Santa Monica, California 90404 |
活跃，非招募 |
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Exelixis Clinical Site #5 加利福尼亚州圣罗莎 95403 |
活跃，非招募 |
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Exelixis Clinical Site #82 Sylmar, California 91342 |
活跃，非招募 |
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Exelixis Clinical Site #58 Torrance, California 90505 |
活跃，非招募 |
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Exelixis Clinical Site #81 Whittier, California 90602 |
活跃，非招募 |
|
Exelixis Clinical Site #125 康涅狄格州纽黑文 06510 |
活跃，非招募 |
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Exelixis Clinical Site #16 佛罗里达州迈阿密海滩 33140 |
活跃，非招募 |
|
Exelixis Clinical Site #60 Orlando, Florida 32804 |
活跃，非招募 |
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Exelixis Clinical Site #4 佐治亚州玛丽埃塔 30060 |
活跃，非招募 |
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Exelixis Clinical Site #3 Joliet, Illinois 60435 |
活跃，非招募 |
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Exelixis Clinical Site #102 Indianapolis, Indiana 46250 |
活跃，非招募 |
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Exelixis Clinical Site #10 堪萨斯州韦斯特伍德 66205 |
活跃，非招募 |
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Exelixis Clinical Site #47 肯塔基州列克星敦 40536 |
活跃，非招募 |
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Exelixis Clinical Site #7 New Orleans, Louisiana 70112 |
活跃，非招募 |
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Exelixis Clinical Site #22 密苏里州圣路易斯 63141 |
活跃，非招募 |
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Exelixis Clinical Site #8 蒙大拿州比林斯 59102 |
活跃，非招募 |
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Exelixis Clinical Site #1 内布拉斯加州奥马哈 68130 |
活跃，非招募 |
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Exelixis Clinical Site #15 新墨西哥州阿尔伯克基 87131 |
活跃，非招募 |
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Exelixis Clinical Site #17 纽约州布朗克斯 10461 |
活跃，非招募 |
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Exelixis Clinical Site #11 纽约州纽约市 10016 |
活跃，非招募 |
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Exelixis Clinical Site #59 纽约州纽约市 10029 |
活跃，非招募 |
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Exelixis Clinical Site #74 Charlotte, North Carolina 28204 |
活跃，非招募 |
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Exelixis Clinical Site #6 俄亥俄州辛辛那提 45219 |
活跃，非招募 |
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Exelixis Clinical Site #12 俄克拉荷马州俄克拉荷马城 73142 |
活跃，非招募 |
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Exelixis Clinical Site #75 Portland, Oregon 97210 |
活跃，非招募 |
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Exelixis Clinical Site #106 宾夕法尼亚州费城 19107 |
活跃，非招募 |
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Exelixis Clinical Site #18 宾夕法尼亚州匹兹堡 15212 |
活跃，非招募 |
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Exelixis Clinical Site #103 宾夕法尼亚州匹兹堡 15232 |
活跃，非招募 |
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Exelixis Clinical Site #24 Greenville, South Carolina 29607 |
活跃，非招募 |
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Exelixis Clinical Site #56 田纳西州查塔努加 37404 |
活跃，非招募 |
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Exelixis Clinical Site #76 田纳西州纳什维尔 37203 |
活跃，非招募 |
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Exelixis Clinical Site #133 田纳西州纳什维尔 37232 |
活跃，非招募 |
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Exelixis Clinical Site #450 弗吉尼亚州费尔法克斯 22031 |
活跃，非招募 |
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Exelixis Clinical Site #14 Roanoke, Virginia 24014 |
活跃，非招募 |
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Exelixis Clinical Site #13 Seattle, Washington 98101 |
活跃，非招募 |
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Exelixis Clinical Site #32 Seattle, Washington 98104 |
活跃，非招募 |
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Exelixis Clinical Site #89 华盛顿州西雅图 98109 |
活跃，非招募 |
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Exelixis Clinical Site #2 Spokane, Washington 99208 |
活跃，非招募 |
| 澳大利亚 | |
|
Exelixis Clinical Site #83 Albury 2640 |
活跃，非招募 |
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Exelixis Clinical Site #53 Bankstown 2200 |
活跃，非招募 |
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Exelixis Clinical Site #117 Bedford Park 5042 |
活跃，非招募 |
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Exelixis Clinical Site #97 Heidelberg 3084 |
活跃，非招募 |
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Exelixis Clinical Site #19 Melbourne 3002 |
活跃，非招募 |
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Exelixis Clinical Site #23 Melbourne 3021 |
活跃，非招募 |
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Exelixis Clinical Site #27 Port Macquarie 2444 |
活跃，非招募 |
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Exelixis Clinical Site #64 Woodville South 5011 |
活跃，非招募 |
| 比利时 | |
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Exelixis Clinical Site #43 Antwerp 2300 |
活跃，非招募 |
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Exelixis Clinical Site #51 Brussels 1200 |
活跃，非招募 |
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Exelixis Clinical Site #35 Namur 5000 |
活跃，非招募 |
| 法国 | |
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Exelixis Clinical Site #52 Besançon 25030 |
活跃，非招募 |
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Exelixis Clinical Site #84 Dijon 21079 |
活跃，非招募 |
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Exelixis Clinical Site #88 Herbault 34298 |
活跃，非招募 |
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Exelixis Clinical Site #71 Lyon 69008 |
活跃，非招募 |
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Exelixis Clinical Site #87 Marseille 13385 |
活跃，非招募 |
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Exelixis Clinical Site #38 Paris 75020 |
活跃，非招募 |
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Exelixis Clinical Site #93 Suresnes 92150 |
活跃，非招募 |
| 德国 | |
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Exelixis Clinical Site #127 Hannover, Niedersach 30625 |
活跃，非招募 |
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Exelixis Clinical Site #109 德累斯顿 01307 |
活跃，非招募 |
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Exelixis Clinical Site #113 Frankfurt am Main 60488 |
活跃，非招募 |
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Exelixis Clinical Site #61 Hamburg 20249 |
活跃，非招募 |
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Exelixis Clinical Site #63 Hamburg 22763 |
活跃，非招募 |
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Exelixis Clinical Site #91 München 81737 |
活跃，非招募 |
| 香港 | |
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Exelixis Clinical Site #25 香港 |
活跃，非招募 |
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Exelixis Clinical Site #33 香港 |
活跃，非招募 |
| Hungary | |
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Exelixis Clinical Site #128 Nyíregyháza, Szabolcs-Szatmar-Bereg County 4400 |
活跃，非招募 |
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Exelixis Clinical Site #41 Budapest 1097 |
活跃，非招募 |
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Exelixis Clinical Site #129 Budapest 1122 |
活跃，非招募 |
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Exelixis Clinical Site #48 Debrecen 4302 |
活跃，非招募 |
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Exelixis Clinical Site #122 Győr 9024 |
活跃，非招募 |
| 大韩民国 | |
|
Exelixis Clinical Site #36 Goyang-si 10408 |
活跃，非招募 |
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Exelixis Clinical Site #29 Gyeonggi-do 14068 |
活跃，非招募 |
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Exelixis Clinical Site #28 Hwasun 58128 |
活跃，非招募 |
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Exelixis Clinical Site #37 Seongnam-si 13620 |
活跃，非招募 |
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Exelixis Clinical Site #34 首尔 03080 |
活跃，非招募 |
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Exelixis Clinical Site #45 首尔 03722 |
活跃，非招募 |
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Exelixis Clinical Site #66 首尔 05505 |
活跃，非招募 |
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Exelixis Clinical Site #46 首尔 06351 |
活跃，非招募 |
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Exelixis Clinical Site #54 Seoul 06591 |
活跃，非招募 |
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Exelixis Clinical Site #44 Seoul 08308 |
活跃，非招募 |
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Exelixis Clinical Site #40 Seoul |
活跃，非招募 |
| 新西兰 | |
|
Exelixis Clinical Site #57 奥克兰 1023 |
活跃，非招募 |
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Exelixis Clinical Site #49 Dunedin 9016 |
活跃，非招募 |
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Exelixis Clinical Site #69 Hamilton 3204 |
活跃，非招募 |
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Exelixis Clinical Site #104 Wellington 6021 |
活跃，非招募 |
| 波兰 | |
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Exelixis Clinical Site #20 Bydgoszcz 85-796 |
活跃，非招募 |
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Exelixis Clinical Site #68 Opole 45-061 |
活跃，非招募 |
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Exelixis Clinical Site #26 Siedlce 08-110 |
活跃，非招募 |
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Exelixis Clinical Site #42 Tomaszów Mazowiecki 97-200 |
活跃，非招募 |
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Exelixis Clinical Site #31 Warszawa 02-507 |
活跃，非招募 |
| 葡萄牙 | |
|
Exelixis Clinical Site #108 Almada 2805-267 |
活跃，非招募 |
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Exelixis Clinical Site #120 Coimbra 3000-075 |
活跃，非招募 |
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Exelixis Clinical Site #99 Guimarães 4835-044 |
活跃，非招募 |
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Exelixis Clinical Site #131 Lisboa 1500-650 |
活跃，非招募 |
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Exelixis Clinical Site #124 里斯本 1649-035 |
活跃，非招募 |
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Exelixis Clinical Site #96 Lisboa 400-038 |
活跃，非招募 |
| 新加坡 | |
|
Exelixis Clinical Site #132 新加坡 119228 |
活跃，非招募 |
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Exelixis Clinical Site #100 新加坡 168583 |
活跃，非招募 |
|
Exelixis Clinical Site #39 Singapore 217562 |
活跃，非招募 |
|
Exelixis Clinical Site #98 Singapore 258499 |
活跃，非招募 |
|
Exelixis Clinical Site #94 Singapore 329563 |
活跃，非招募 |
| 西班牙 | |
|
Exelixis Clinical Site #78 Barcelona 08023 |
活跃，非招募 |
|
Exelixis Clinical Site #21 Barcelona 08025 |
活跃，非招募 |
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Exelixis Clinical Site #86 巴塞罗那 08035 |
活跃，非招募 |
|
Exelixis Clinical Site #112 Barcelona 08908 |
活跃，非招募 |
|
Exelixis Clinical Site #95 Lleida 25198 |
活跃，非招募 |
|
Exelixis Clinical Site #116 Madrid 28007 |
活跃，非招募 |
|
Exelixis Clinical Site #72 马德里 28034 |
活跃，非招募 |
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Exelixis Clinical Site #67 马德里 28041 |
活跃，非招募 |
|
Exelixis Clinical Site #79 马德里 28050 |
活跃，非招募 |
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Exelixis Clinical Site #90 Valencia 46014 |
活跃，非招募 |
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Exelixis Clinical Site #121 Zaragoza 50009 |
活跃，非招募 |
| 台湾 | |
|
Exelixis Clinical Site #119 Guishan 333 |
活跃，非招募 |
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Exelixis Clinical Site #85 Kaohsiung 807 |
活跃，非招募 |
|
Exelixis Clinical Site #107 Kaohsiung 833 |
活跃，非招募 |
|
Exelixis Clinical Site #118 Liuying 73657 |
活跃，非招募 |
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Exelixis Clinical Site #73 Taichung 40447 |
活跃，非招募 |
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Exelixis Clinical Site #101 Tainan 704 |
活跃，非招募 |
| 泰国 | |
|
Exelixis Clinical Site #62 Chiang Mai 50200 |
活跃，非招募 |
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Exelixis Clinical Site #92 Hat Yai 90110 |
活跃，非招募 |
| 英国 | |
|
Exelixis Clinical Site #130 Bristol, England BS2 8ED |
活跃，非招募 |
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Exelixis Clinical Site #110 Birmingham B95SS |
活跃，非招募 |
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Exelixis Clinical Site #111 Edinburgh EH42XU |
活跃，非招募 |
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Exelixis Clinical Site #123 London EC1A 7BE |
活跃，非招募 |
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Exelixis Clinical Site #114 London W1G 6AD |
活跃，非招募 |
|
Exelixis Clinical Site #115 Romford RM70AG |
活跃，非招募 |
|
Exelixis Clinical Site #126 萨顿 SM2 5PT |
活跃，非招募 |
纳入标准
纳入标准
* Subjects with histologically or cytologically confirmed adenocarcinoma of the colon or rectum.
* Documented RAS status (mutant or wild-type [WT]), by tissue-based analysis.
* Documented NOT to have microsatellite instability-high (MSI-high) or mismatch repair deficient (dMMR) CRC by tissue-based analysis.
* Has received standard-of-care (SOC) anticancer therapies as prior therapy for metastatic CRC and has radiographically progressed, is refractory or intolerant to these therapies.
* Systemic SOC anticancer therapy if approved and available in the country where the subject is randomized.
* Radiographic progression during treatment with or within 4 months following the last dose of the most recent approved SOC chemotherapy regimen.
* Measurable disease according to RECIST v1.1 as determined by the Investigator.
* Available archival tumor biopsy material. If archival tissue is unavailable, must provide fresh tumor tissue biopsy prior to randomization.
* Recovery to baseline or ≤ Grade 1 severity (CTCAE v5) from adverse events (AEs) related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy.
* Age 18 years or older on the day of consent.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
* Adequate organ and marrow function.
* Fertile subjects and their partners must agree to use highly effective methods of contraception during the course of the study and after the last dose of treatment.
* Female subjects of childbearing potential must not be pregnant at screening.
排除标准
排除标准：
* Prior treatment with XL092, regorafenib, trifluridine/tipiracil, or PD-L1/PD-1 targeting immune checkpoint inhibitors (ICIs).
* Receipt of a small molecule kinase inhibitor (including investigational agents) within 2 weeks before randomization.
* Receipt of any type of anticancer antibody therapy, systemic chemotherapy, or hormonal anti-cancer therapy within 3 weeks (or bevacizumab within 4 weeks) before randomization.
* Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 4 weeks before randomization.
* Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks before randomization.
* Subject has uncontrolled, significant intercurrent or recent illness.
* Major surgery (e.g., GI surgery, removal or biopsy of brain metastasis) within 4 weeks prior to randomization.
* Systemic treatment with, or any condition requiring, either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days prior to randomization.
* Corrected QT interval calculated by the Fridericia formula (QTcF) > 460 ms within 10 days before randomization.
* History of psychiatric illness likely to interfere with ability to comply with protocol requirements or give informed consent.
* Pregnant or lactating females.
* Inability to swallow study treatment formulation, inability to receive IV administration, or presence of GI condition that might affect the absorption of study drug.
* Previously identified allergy or hypersensitivity to components of the study treatment formulations.
* Any other active malignancy or diagnosis of another malignancy within 2 years before randomization. Exceptions are noted in the protocol.
* Administration of a live, attenuated vaccine within 30 days before randomization.
