A Randomized, Open, Multicenter Phase III Clinical Trial of Combination of Sintilimab Injection (IBI308) and XELOX+Bevacizumab Compared With XELOX+Bevacizumab as 1st Line Therapy of RAS-Mutant Metastatic Colorectal Cancer

Who is this study for? Patients with Ras gene mutant advanced colorectal cancer
What treatments are being studied? IBI308
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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)

• When there is no liver metastasis, ALT or AST is less than or equal to 2.5 times the upper limit of the normal value reference range, serum total bilirubin is less than or equal to 1.5 times the upper limit of the normal value reference range; for patients with liver metastasis, ALT or AST is less than or equal to 5 times the upper limit of the normal value reference range, serum total bilirubin is less than or equal to 3 times the upper limit of the normal value reference range

⁃ Women of childbearing age must be willing to use adequate contraception during study drug treatment

⁃ Informed consent has been signed

⁃ According to the definition of RECIST 1.1, the investigator determined that the patient had a measurable disease. Tumor lesions located in previous radiotherapy areas are considered measurable if they demonstrate progression.

Locations
Other Locations
China
Xuefeng Fang
RECRUITING
Hangzhou
Contact Information
Primary
XUEFENG FANG
xffang@zju.edu.cn
057187784718
Backup
Ying Yuan
yuanying1999@zju.edu.cn
Time Frame
Start Date: 2022-02-08
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 446
Treatments
Experimental: Sintilimab + XELOX + Bevacizumab
Sintilimab + XELOX + Bevacizumab
Active_comparator: XELOX + Bevacizumab
XELOX + Bevacizumab
Related Therapeutic Areas
Sponsors
Leads: Second Affiliated Hospital, School of Medicine, Zhejiang University

This content was sourced from clinicaltrials.gov

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