Combination With Sintilimab and XELOX+Bevacizumab as 1st Line Therapy in RAS-mutant Metastatic Co… (NCT05171660) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Combination With Sintilimab and XELOX+Bevacizumab as 1st Line Therapy in RAS-mutant Metastatic Colorectal Cancer
China446 participantsStarted 2022-02-08
Plain-language summary
Sintilimab (R\&D code: IBI308) is a recombinant human-derived IgG4 type PD-1 monoclonal antibody. PD-1 inhibitor combined with chemotherapy has synergistic effect to further enhance anti-tumor immunity. This study is a phase III clinical study of a three-week regimen of sintilimab combined with the XELOX+ bevacizumab for RAS-mutant metastatic colorectal cancer patients who had not received any treatment before. The purpose of this study is to explore the efficacy of sintilimab combined with XELOX + bevacizumab as first line therapy.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Male or female, age ≥ 18 years old, ≤ 75 years old
✓. Metastatic colorectal adenocarcinoma confirmed by histology, metastases cannot be removed
✓. RAS mutation, BRAF V600E wild type, and microsatellite stable
✓. ECOG 0 to 1
✓. Life expectancy is at least 12 weeks
✓. Hematological examination absolute neutrophil count (ANC)\>1.5×109/L, hemoglobin\>8g/dL and platelet\>100×109/L (according to the normal value of clinical trial center)
✓. Prothrombin time (PT) \< 1.5 times the upper limit of normal value and normal thromboplastin time (APTT) \< 1.5 times the upper limit of normal value
✓. Laboratory examination, serum creatinine is less than or equal to 1.5 times the upper limit of the normal reference range (if serum creatinine is elevated, 24 hours of urine must be collected, except for 24 hours creatinine clearance \> 50ml/min)
Exclusion criteria
✕
What they're measuring
1
Progression free survival time
Timeframe: From randomization to the first documented disease progression, or to death from any cause, up to 2 years
Trial details
NCT IDNCT05171660
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
. Active autoimmune disease requiring systemic treatment occurred in the previous 2 years.
✕. Diagnosed as immunodeficiency or experimental treatment is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose. After consultation with the sponsor, the use of a physiological dose of corticosteroids may be approved.
✕. Adverse events caused by anti-tumor monoclonal antibodies (mAbs) within 4 weeks prior to study day 1 or drugs received 4 weeks prior to the study have not recovered.
✕. Adverse events caused by chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study day 1, or previously received drugs, have not recovered (ie, ≤1 or reached baseline levels).
✕. Active central nervous system (CNS) metastasis and/or cancerous meningitis are known to exist.
✕. There are active infections that require systemic treatment.
✕. It is possible to confuse the test results, the medical history or disease evidence, the treatment or laboratory value abnormalities that hinder the subject's full participation in the study, or the investigator believes that participating in the study is not in the best interests of the subject.
✕. There are known mental or substance abuse disorders that may have an impact on compliance with test requirements.