临床试验搜索器

纳入标准

纳入标准

Participants must have histologically or cytologically confirmed adenocarcinoma of colorectal origin
Age >18 years.
ECOG performance status <1
预期寿命超过 3 个月

参试者的器官和骨髓功能必须正常，如表 1 所示，所有筛查实验室检查应在方案注册后 14 天内进行。

Table 1 Adequate Organ Function Laboratory Values:

系统实验室值

血液学

Absolute neutrophil count (ANC) ≥1000 /mcL
白细胞计数（WBC）≥2000 /mcL
Platelets ≥75,000 / mcL
Hemoglobin ≥7.5 g/dL

肾脏

Serum creatinine OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl)≤ Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl)

40 mL/min (if using the Cockcroft-Gault formula below): Female CrCl = (140 - age in years) x weight in kg x 0.85 72 x serum creatinine in mg/dL Male CrCl = (140 - age in years) x weight in kg x 1.00 72 x serum creatinine in mg/dL

肝脏

Serum total bilirubin ≤ 1.5 X ULN (subjects with Gilbert Syndrome can have a total bilirubin 1 cm in size (>15 mm for nodal disease) outside the radiation field that can be used as measurable disease.
Colorectal patients must have documentation of microsatellite status: MSS or pMMR.

Immunohistochemistry (IHC) and/or PCR is acceptable.

Colorectal patients must have received any prior combination of Fluorouracil (5FU), Irinotecan and Oxaliplatin, or have a contraindication/intolerance to receiving these agents.

Patients may have received these agents all together or sequentially.

排除标准

排除标准：

在方案治疗后 14 天内接受过化疗、小分子靶向治疗或研究疗法的受试者，或因 2 周前用药导致的不良事件尚未痊愈（即≤ 1 级或基线）的受试者。≤2级神经病变的受试者不在此标准之列，可能符合研究条件。如果受试者接受过大手术，则必须在开始治疗前已从手术毒性和/或并发症中充分恢复。
Patients who have had radiation within 8 weeks prior to protocol registration.
正在接受任何其他研究药物治疗的参试者。
Patients are excluded if they have an active, known or suspected autoimmune disease other than those listed below. Subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger.
Patients are excluded if they have a condition requiring systemic treatment with either corticosteroids (> 12 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 12 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Subjects are permitted to use topical, ocular, intraarticular, intranasal, and inhalational corticosteroids (with minimal systemic absorption).

Physiologic replacement doses of systemic corticosteroids are permitted, even if > 12 mg/day prednisone equivalents. A brief course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted.

Patients are excluded if they have previously received anti-CTLA-4 therapy. Prior anti- PD-1 or anti-PD-L1 therapy is permitted with 6-month washout period unless the following treatment-related toxicities are present:

Any toxicity NCI CTCAE grade >/= 3 from previous immunotherapy that did not resolve to grade 1 with or without immunosuppressive therapy. Patients must be off all immunosuppressive therapy prior to enrollment.
Myocarditis, any grade.
Pneumonitis, any grade.
Patients with grade 2 hepatitis or colitis will be evaluated on a case-by-case basis and may be included only after consultation with a Gastroenterologist and the study physician.
已知有活动性肺结核（结核杆菌病）病史。
No active or chronic HBV or HCV. Patients are excluded if they have a positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection. Subjects with a history of HBV or HCV require documentation of treatment completion, further testing is not required.
Patients are excluded if they have known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).

These participants are at increased risk of lethal infections when treated with marrow suppressive therapy. Appropriate studies will be undertaken in participants receiving combination antiretroviral therapy when indicated.

无法控制的并发症，包括但不限于持续或活动性感染、有症状的充血性心力衰竭、不稳定型心绞痛、心律失常或精神疾病/社会状况，这些都会限制对研究要求的遵守。
患有已知的精神疾病或药物滥用疾病，会影响配合试验要求。
在试验的预计持续时间内，即从预检或筛查访问开始，到试验治疗最后一次用药后 5 个月（女性）和 7 个月（男性），正在怀孕或哺乳，或准备怀孕或生育。
Has a known additional malignancy that is progressing or requires active treatment.

Exceptions include basal cell carcinoma of the skin and squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.

有活动性非感染性肺炎病史或任何相关证据。
患有需要系统治疗的活动性感染。
Has received a live/attenuated vaccine within 30 days of planned start of study therapy.

Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.

History of allergy to study drug components.
History of severe hypersensitivity reaction to any monoclonal antibody.
Uncontrolled brain metastases. Patients treated with radiation > 4 weeks prior with follow up imaging showing control are eligible