ibi308 Combined With Bevacizumab + XELOX Regimen in Advanced Colorectal Cancer

  • STATUS
    Recruiting
  • End date
    Dec 12, 2023
  • participants needed
    23
  • sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University
Updated on 9 January 2022

Summary

a phase II clinical study of IBI308 combined with bevacizumab + XELOX regimen in the treatment of patients with metastatic colorectal cancer. a total of 8 courses of medication would be given. A total of 25 patients are planned to be enrolled.

Description

This study is a phase II clinical study of IBI308 combined with bevacizumab + XELOX regimen in the treatment of patients with metastatic colorectal cancer who have not been treated every three weeks. The study treatment took 21 days as a treatment cycle. IBI308, bevacizumab and oxaliplatin were given intravenously on the first day of each cycle, and capecitabine was given from the first day to the 14th day. All adverse events will be graded according to NCI CTCAE (version 4.0); During the treatment, CT was rechecked every 2 courses to evaluate the curative effect. If the curative effect was evaluated as Cr, PR, SD or non Cr / non PD, the treatment scheme would continue. It is estimated that a total of 8 courses of medication would be given, and then rechecked every 3 months until the disease progresses.

A total of 25 patients are planned to be enrolled. When the number of subjects reaches 25 respectively, the enrollment ends to inquire about the safety and efficacy of IBI308 combined with bevacizumab + XELOX.

Details
Condition Colorectal Cancer Stage IV
Treatment IBI308
Clinical Study IdentifierNCT05171660
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
Last Modified on9 January 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female, age ≥ 18 years old, ≤ 75 years old
Metastatic colorectal adenocarcinoma confirmed by histology, metastases cannot be removed
RAS gene mutation
ECOG performance status of 0-1
Life expectancy≥3 months
Adequate organ and bone marrow functions
Neutrophils >1.5×109/L, platelets >100×109/L, and hemoglobin >9 g/dL; Total
bilirubin <1.5×upper limit of normal (ULN); aspartate aminotransferase
(AST)/serum glutamic-oxaloacetic transaminase (SGOT) and/or alanine
aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT) <2.5×ULN
(<5×ULN in case of liver metastases); Creatinine clearance (calculated
according to Cockcroft and Gault)
mL/min; Urinary protein / creatinine ratio < 1 (or urine analysis < 1 + or 24-hour urinary protein < 1g / 24 h)
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, tumor lesions are considered measurable if they demonstrate progression

Exclusion Criteria

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)
Female subjects who are pregnant or lactating, or who are expected to be pregnant during the planned trial period (from 120 days after screening visits to 120 days after the last dose of study treatment, or 180 days after the last dose of study treatment), or Male subjects whose spouse is pregnant
History of infection with human immunodeficiency virus (HIV) (HIV 1/2 antibody) is known
Active hepatitis B or C
Live vaccines were vaccinated within 30 days of the start date of the study treatment plan
RAS wild type
Clear my responses

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