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AzTrials

Colorectal Cancer Stage IVPhase 3NCT05171660

Combination With Sintilimab and XELOX+Bevacizumab as 1st Line Therapy in RAS-mutant Metastatic Colorectal Cancer

A Phase 3 study testing Sintilimab, Bevacizumab and Oxaliplatin in people with Colorectal Cancer Stage IV, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Colorectal Cancer Stage IV
What is being tested?
Sintilimab, Bevacizumab and Oxaliplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
446 participants
Where
1 siteChina
Study dates
8 Feb 2022to 30 Dec 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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.

Who cannot join

  • 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).
  • Other malignancies that are progressing or require active treatment are known. Except for basal cell carcinoma, cutaneous squamous cell carcinoma, or cervical carcinoma in situ that have undergone radical treatment.
  • Active central nervous system (CNS) metastasis and/or cancerous meningitis are known to exist.
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  • 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.
  • 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.
  • A 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Xuefeng Fang

    Hangzhou, Zhejiang, 310009

Other trials in China

About this study

Official title: 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

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.

Keywords
Colorectal Cancer Stage IV,, RAS gene mutation, Microsatellite stable
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SintilimabDrug

    Sintilimab Injection: 200 mg, i.v., D1, Q3W

  • BevacizumabDrug

    intravenous bevacizumab (7.5 mg/kg, day 1) in each 21-day cycle

  • OxaliplatinDrug

    intravenous oxaliplatin (130 mg/m2, day 1) in each 21-day cycle

  • CapecitabineDrug

    oral capecitabine (1 g/m2, days 1-14) in each 21-day cycle

Study groups in NCT05171660
Study groupRoleWhat they receive
Sintilimab + XELOX + BevacizumabExperimentalSintilimab + XELOX + Bevacizumab
Receives: Drug: Sintilimab; Drug: Bevacizumab; Drug: Oxaliplatin; Drug: Capecitabine
XELOX + BevacizumabActive comparatorXELOX + Bevacizumab
Receives: Drug: Bevacizumab; Drug: Oxaliplatin; Drug: Capecitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival time

    Progression-free survival is defined as the time from randomization to the first documented disease progression according to RECIST version 1.1, or to death from any cause, whichever occurred first.

    Measured: From randomization to the first documented disease progression, or to death from any cause, up to 2 years

Secondary outcomes (5)

  1. Objective Response Rate

    According to RECIST 1.1 criteria, the proportion of patients whose tumor efficacy was evaluated as CR and PR among all evaluable patients

    Measured: From randomization to disease progression

  2. Overall survival time

    Time from randomization to death from any cause

    Measured: From randomization to death from any cause, up to 3 years

  3. Disease control rate

    According to RECIST 1.1 criteria, the proportion of subjects whose tumor efficacy was evaluated as CR, PR and SD among all evaluable patients

    Measured: From randomization to disease progression

  4. Clinical benefit rate

    The proportion of patients who achieved CR PR or maintained SD for a certain period of time (6 months)

    Measured: From randomization to disease progression

  5. Adverse Events

    Incidence of AEs (all grades), incidence of grade 1-2 AEs, incidence of grade 3-4 AEs, incidence of grade 5 AEs, treatment discontinuation rate, discontinuation rate due to adverse reactions, all subjects who used at least one study drug were included

    Measured: From randomization to 28 days after disease progression

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Dec 2021
  2. Study start8 Feb 2022
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
446 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05171660
Sponsor's protocol ID
2021-1013
Status last verified
Feb 2026
First submitted
8 Nov 2021
Last updated
17 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Fang X, Zhong C, Weng S, Hu H, Wang J, Xiao Q, Wang J, Sun L, Xu D, Liao X, Dong C, Zhang S, Li J, Ding K, Yuan Y. Sintilimab plus bevacizumab and CapeOx (BBCAPX) on first-line treatment in patients with RAS mutant, microsatellite stable, metastatic colorectal cancer: study protocol of a randomized, open-label, multicentric study. BMC Cancer. 2023 Jul 18;23(1):676. doi: 10.1186/s12885-023-11139-z.

    PubMed 37464378

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sintilimab, Bevacizumab and Oxaliplatin in people with Colorectal Cancer Stage IV, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival time (time frame: From randomization to the first documented disease progression, or to death from any cause, up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05171660, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.

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