ibi308 Combined With Bevacizumab + XELOX Regimen in Advanced Colorectal Cancer

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


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.


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.

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


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

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact



Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note