计划状态
招聘阶段
第二阶段允许先接受免疫治疗
没有CRC 指导的试验
是药物
5-Fluorouracil, Bevacizumab, capecitabine, Irinotecan, Leucovorin, oxaliplatin标签
MSS/ MMRp评论
Trial in China, for patients with metastatic MSS only CRC.
First part for patients receiving first line therapy for metastatic disease; second part admits patients who already received standard of care therapy.
之前未接受过免疫疗法。
AK112 (ivonescimab): tetravalent Fc-silent bispecific antibody with dual blockade of PD-1 and VEGF. Immunotherapy, since includes anti PD-1.
AK117 (ligufalimab): anti-CD47 antibody; immunotherapy.
Ongoing trial; signs of efficacy and safety (see ESMO 2024, Helpful Links)
有用链接
https://www.annalsofoncology.org/article/S0923-7534(24)02102-1/fulltext https://aacrjournals.org/mct/article/22/12_Supplement/B123/730794/Abstract-B123-Mechanism-of-action-of-ivonescimab https://jitc.bmj.com/content/10/11/e005517| 地点 | 位置状态 |
|---|---|
| 美国 | |
|
Summit Therapeutics Research Site 加利福尼亚州洛杉矶 90067 |
招聘 |
| 中国 | |
|
The Sixth Hospital,Sun Yat-sen University Guanzhou, Guangdong 510000 |
招聘 |
联系方式
纳入标准
纳入标准
* Histologically proven diagnosis of colorectal adenocarcinoma
* Part1: Subjects who have not previously received any systemic antitumor therapy and who have previously received neoadjuvant or adjuvant therapy, the first detection of recurrence or metastasis should be ≥12 months after the last administration of neoadjuvant or adjuvant therapy
* Part2: Subjects who have previously received systemic therapy including fluorouracil, oxaliplatin, irinotecan, bevacizumab or anti-EGFR antibodies or could not tolerate or have contraindications to standard treatment
* Eastern Cooperative Oncology Group performance status of 0 or 1
* Measurable disease as defined by RECIST v1.1
* Adequate hematologic and organ function
排除标准
排除标准：
* Known MSI-H(Microsatellite-Instability-High) or dMMR(Mismatch Repair-Deficient)
* Prior treatment with immunotherapy, including immune checkpoint inhibitors , immune checkpoint agonists, immune cell therapy and any treatment targeting tumor immune pathway
* History of autoimmune disease
* Prior allogeneic stem cell or solid organ transplantation
* Positive test for human immunodeficiency virus,Active hepatitis B or hepatitis C
* Receipt of a live, attenuated vaccine within 30 days prior to randomization, during treatment
* Pregnancy or lactation
* Dysphagia
