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Colorectal Cancer MetastaticPhase 2NCT06973343

Sintilimab Plus Bevacizumab and Chemotherapy in MSS/pMMR Colorectal With no Liver Metastasis

A Phase 2 study testing Group A and Group B in people with Colorectal Cancer Metastatic, run by Anhui Provincial Cancer Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This is a non-randomized, open-label, single-center clinical trial to evaluate efficacy and safety of sintilimab plus bevacizumab and chemotherapy on treatment in patients with advanced no liver metastatic MSS/pMMR colorectal cancer Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer Metastatic
What is being tested?
Group A and Group B
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
May 2025to Dec 2027
Phase
Phase 2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Sign written informed consent before implementing any experimental procedures
  • Over 18 years old
  • Histologically confirmed as colorectal adenocarcinoma without liver metastasis
  • At least one measurable lesion (RECIST 1.1)
  • Satellite stable (MSS) or low instability (MSI-L) or normal expression of DNA mismatch repair genes (pMMR)
  • ECOG PS score is 0-1
Show all 19Show fewer
  • Progress after initial treatment or standard first-line treatment
  • Have sufficient organ and bone marrow function
  • Expected to survive for more than 3 months
  • Participants must have normal hematological test results, including：
  • absolute neutrophil count (ANC) greater than 1.5 × 109/L
  • hemoglobin greater than 8 g/dL
  • platelet count greater than 80-100 × 109/L
  • Participants' prothrombin time (PT) must be less than 1.5 times the upper limit of normal values, and activated partial thromboplastin time (APTT) must be less than 1.5% of the upper limit of abnormal values
  • Participants must have normal laboratory test results, including：serum creatinine levels less than or equal to 1.5 times the upper limit of the normal reference range, or creatinine clearance rates greater than 50 ml/min
  • For participants without liver metastasis, their alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels must be less than or equal to 2.5 times the upper limit of the normal reference range, and their serum total bilirubin levels must be less than 1.5 times the upper limit of the normal reference range
  • For female subjects of childbearing age, a urine or serum pregnancy test with negative results should be conducted within 3 days prior to the first administration of the study drug (Day 1 of the first cycle)
  • If there is a risk of conception, all subjects must use contraceptive measures with an annual failure rate of less than 1% throughout the entire treatment period until 120 days after the last administration of the study drug
  • The subjects must agree to provide sufficient tumor tissue samples for PD-L1 expression detection

Who cannot join

  • Known presence of active central nervous system (CNS) metastases and/or cancerous meningitis
  • Microsatellite instability (MSI-H) or loss of expression of DNA mismatch repair genes (dMMR)
  • Currently participating in interventional clinical research treatment, or having received other research drugs or used research instruments for treatment within 4 weeks before the first administration
  • Previously received the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs, or drugs that stimulate or synergistically inhibit T cell receptors
  • Within 2 years prior to the first administration, there has been an active autoimmune disease requiring systemic treatment
  • Imaging shows tumor invasion/infiltration into large blood vessels, or researchers or radiologists assess a tendency towards bleeding
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  • Have undergone major surgical treatment within 4 weeks prior to the initial administration of the investigational drug (excluding surgery for biopsy purposes) or are expected to undergo major surgery during the study period
  • Severe unhealed wounds, ulcers, or fractures
  • Undertook minor surgeries within 48 hours prior to the first receipt of the study drug
  • Currently or recently (within 10 days prior to receiving the first dose of the study drug) using aspirin (>325 mg/day) or other known nonsteroidal anti-inflammatory drugs that can inhibit platelet function for 10 consecutive days
  • Currently or recently (within 10 days prior to receiving the first dose of the study drug), using full dose oral or parenteral anticoagulants or thrombolytic agents for treatment for 10 consecutive days
  • There is a genetic tendency for bleeding or coagulation dysfunction, or a history of thrombosis
  • Known allogeneic organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation
  • Individuals known to be allergic to the active ingredients of the study drug
  • Prior to commencing treatment, the individual has not fully recovered from any toxicity and/or complications caused by any intervention measures (i.e., ≤ grade 1 or baseline, excluding fatigue or hair loss)
  • Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive)
  • Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number detected is greater than the upper limit of normal value in the laboratory of the research center)
  • Pregnant or lactating women
  • The presence of any serious or uncontrollable systemic disease
  • 21. Other situations that the researchers believe are not suitable for inclusion, or other potential risks that are not suitable for participation in this study

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Wang Gang contact

13855196707

wanggang829@126.com

China1 site

  • Anhui provincial cancer hospital

    Hefei, Anhui, 230000

    Gang Wang, +86-13855196707, wanggang829@126.com

Other trials in China

About this study

Official title: Sintilimab Plus Bevacizumab and Chemotherapy on Treatment in Patients With Advanced no Liver Metastatic MSS/pMMR Colorectal Cancer: Phase II Cohort Study

This is a non-randomized, open-label, single-center clinical trial to evaluate efficacy and safety of sintilimab plus bevacizumab and chemotherapy on treatment in patients with advanced no liver metastatic MSS/pMMR colorectal cancer

Read the detailed description

The regimen involves 3-week cycles with bevacizumab (7.5 mg/m2 on days 1) and fixed doses of sintilimab (200 mg on day 1) and chemotherapy. The primary endpoint is progression-free survival (PFS). Secondary endpoints are Objective response rate(ORR), Disease control rate(DCR), Overall survival(OS) and quality of life. Adverse events are monitored and graded according to the Common Terminology Criteria for Adverse Events version 4.0.

Being tested
Group A, Group B

What participants receive

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

  • Group ADrug

    Also called Untreated

    Sintilimab 200mg Bevacizumab 7.5mg/kg Oxaliplatin 130mg/m2 Capecitabine 1250mg/m2

  • Group BDrug

    Also called After systematic treatment

    Sintilimab 200mg Bevacizumab 7.5mg/kg Irinotecan 150mg/m2 Capecitabine 1250mg/m2

Study groups in NCT06973343
Study groupRoleWhat they receive
Patients who have not received systematic treatment in the pastExperimentalSintilimab 200mg+ Bevacizumab 7.5mg/kg+Oxaliplatin 130mg/m2+Capecitabine 1250mg/m2 for 6-8cycles, Sintilimab 200mg+ Bevacizumab 7.5mg/kg+Capecitabine 1250mg/m2 as maintenance treatment until disease progression or intolerable toxic side effects occur
Receives: Drug: Group A
Patients who have received first-line systemic treatment in the pastExperimentalSintilimab 200mg+ Bevacizumab 7.5mg/kg+Irinotecan 150mg/m2+Capecitabine 1250mg/m2 for 6-8cycles, Sintilimab 200mg+ Bevacizumab 7.5mg/kg+Capecitabine 1250mg/m2 as maintenance treatment until disease progression or intolerable toxic side effects occur
Receives: Drug: Group B

What is being measured

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

  1. PFS

    Progression free survival

    Measured: through study completion, an average of 1 year

Secondary outcomes (4)

  1. ORR

    Objective response rate

    Measured: up to 24 weeks

  2. DOR

    Duration of response

    Measured: up to 24 weeks

  3. DCR

    Disease control rate

    Measured: up to 24 weeks

  4. OS

    Overall survival

    Measured: through study completion, an average of 2 year

Timeline

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

  1. First posted15 May 2025
  2. Study startMay 2025 (estimated)
  3. Primary completionFeb 2026 (estimated)
  4. Study completionDec 2027 (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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06973343
Sponsor's protocol ID
2025004
Status last verified
Jan 2025
First submitted
21 Feb 2025
Last updated
15 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Protecting patient privacy

Publications

  • Fukuoka S, Hara H, Takahashi N, Kojima T, Kawazoe A, Asayama M, Yoshii T, Kotani D, Tamura H, Mikamoto Y, Hirano N, Wakabayashi M, Nomura S, Sato A, Kuwata T, Togashi Y, Nishikawa H, Shitara K. Regorafenib Plus Nivolumab in Patients With Advanced Gastric or Colorectal Cancer: An Open-Label, Dose-Escalation, and Dose-Expansion Phase Ib Trial (REGONIVO, EPOC1603). J Clin Oncol. 2020 Jun 20;38(18):2053-2061. doi: 10.1200/JCO.19.03296. Epub 2020 Apr 28.

    PubMed 32343640

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Group A and Group B in people with Colorectal Cancer Metastatic, run by Anhui Provincial Cancer Hospital 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 19 inclusion and 20 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: opening soon, as of the sponsor's last update on 15 May 2025. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Contact Wang Gang (13855196707, wanggang829@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS (time frame: through study completion, an average of 1 year). 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 NCT06973343, 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 15 May 2025.

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