Colorectal cancer
Conditions
Interventions
Experimental group:Sintilimab and Regorafenib
Sponsors
Shanxi Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged >= 18, male or female; 2. Pathologically confirmed advanced unresectable colorectal adenocarcinoma with MSS type; 3. Failure or intolerance of at least two systemic treatment regiments (disease progression during treatment of fluorouracil, oxaliplatin and irinotecan or recurrence within 6 months after completion of treatment, first-line and second-line systemic treatment must be >= 1 cycle); 4. Have at least one measurable lesion (RECIST1.1) with spiral CT or MR target lesion >= 10 mm and lymph node >= 15 mm; 5. Estimated survival >= 3 months; 6. ECOG 0-2; 7. The functions of vital organs meet the following requirements (it is not recommended to use any blood components and cell growth factors 2 weeks before the start of the study) : (1) TBIL of total bilirubin = 45 ml/min; (5) Hemoglobin Hb >= 90 g/L; (6) Absolute neutrophil count ANC >= 1.5 x 10^9/L; (7) Platelet count PLT >= 75 x 10^9/L; (8) albumin ALB >= 29 g/L; (9) INR = 2+, the 24-hour urine protein quantitative display protein must be 1 g or less; (12) Thyroid stimulating hormone (TSH) <= the upper limit of normal (ULN); if abnormal, FT3 and FT4 levels should be examined, and normal FT3 and FT4 levels can be selected; 8. Negative pregnancy tests for women of childbearing age; women of reproductive age were willing to use a highly effective method of contraception during the trial period and within 60 days after the last dose; male subjects whose partners were women of reproductive age agreed to use a highly effective method of contraception during the trial period and for 120 days after the last administration of the trial drug; 9. Volunteer to join and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Previously received PD-1/PD-L1 antibody, CTLA-4 antibody, or other small molecule inhibitors against PD-1/PD-L1 and/or VEGFR (antivascular therapy > 6 months can be included); 2. Hypertension that cannot be well controlled by antihypertensive medication (systolic blood pressure >= 140 mmHg or diastolic blood pressure >= 90 mmHg); 3. Multiple factors affecting oral medication (such as inability to swallow); 4. Patients with abnormal coagulation function (INR > 1.5 or APTT > 1.5 x ULN), bleeding tendency or receiving thrombolytic or anticoagulant therapy (prophylactic use of low-dose aspirin and low-molecular weight heparin is allowed), bleeding tendency; 5. Patients with clinically significant bleeding symptoms or clear bleeding tendency (such as gastrointestinal bleeding, hemorrhagic gastric ulcer, etc.) within 3 months before the study; 6. Arteriovenous thrombosis events, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, occurred within 6 months before the study; 7. The presence or history of any active autoimmune disease (including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism); subjects with vitiligo or asthma in complete remission during childhood without any intervention as adults could be included; subjects with asthma requiring medical intervention with bronchodilators were excluded); 8. Use of immunosuppressive drugs within 14 days prior to the first use of Sindilizumab, excluding nasal spray and inhaled corticosteroids or physiological doses of systemic steroids (i.e., no more than 10 mg/day of prednisolone or other corticosteroid at pharmacologic equivalent dose); 9. Subjects who have been treated with antitumor vaccine or other immune-stimulating antitumor agents (interferon, interleukinin, thymosin, immunocell therapy, etc.) within 1 month before the first administration; subjects who received or will receive live vaccine within 30 days prior to initial administration; 10. Patients who were treated with a large dose of antibiotics within 1 month before the first medication; 11. Known uncontrolled or symptomatic active central nervous system (CNS) metastases presenting with clinical symptoms, cerebral edema, spinal cord compression, cancerous meningitis, pia meningeal disease, and/or progressive growth. Patients with a history of CNS metastasis or spinal cord compression may be enrolled if they are clearly treated and their clinical performance is stable 4 weeks after anticonvulsant and steroid withdrawal prior to study initial administration; 12. Subjects with severe/unstable angina pectoris, grade ? or higher myocardial ischemia or myocardial infarction, and poorly controlled arrhythmias (including QTc intervals >= 450 ms for males and >= 470 ms for females) within 6 months prior to study entry. Subjects with NYHA grade III-IV cardiac insufficiency or color doppler echocardiography (LVEF) < 50% were excluded. Patients with symptomatic congestive heart failure, cerebrovascular accident (including transient ischemic attack or symptomatic pulmonary embolism); 13. Currently accompanied by active interstitial pneumonia or interstitial lung disease, or has a need to hormone treatment of interstitial pneumonia or history of interstitial lung disease, or have other may interfere with the immun
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| DCR (Disease Control Rate);DOR (Duration of Response);PFS (Progress-Free Survival);OS (Overall Survival); | — |
Primary
| Measure | Time frame |
|---|---|
| ORR (Objective Response Rate); | — |
Countries
China
Contacts
Public ContactWang Yusheng
Shanxi Cancer Hospital
Outcome results
None listed