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

NCT06973343 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: 2025004
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Colorectal Cancer Metastatic

Outcome Measures

Primary Outcomes (1)

• PFS

  Progression free survival

  through study completion, an average of 1 year

Secondary Outcomes (4)

• ORR

  up to 24 weeks

• DOR

  up to 24 weeks

• DCR

  up to 24 weeks

• OS

  through study completion, an average of 2 year

Study Arms (2)

Patients who have not received systematic treatment in the past

EXPERIMENTAL

Sintilimab 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

Drug: Group A

Patients who have received first-line systemic treatment in the past

EXPERIMENTAL

Sintilimab 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

Drug: Group B

Interventions

Group A DRUG

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

Also known as: Untreated

Patients who have not received systematic treatment in the past

Group B DRUG

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

Also known as: After systematic treatment

Patients who have received first-line systemic treatment in the past

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Anhui Provincial Cancer Hospital: lead

Study Sites (1)

Anhui provincial cancer hospital

Hefei, Anhui, 230000, China

Location

Related Publications (1)

• 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.

  PMID: 32343640 BACKGROUND

Central Study Contacts

Wang Gang

CONTACT

13855196707; wanggang829@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: February 21, 2025
• First Posted: May 15, 2025
• Study Start: May 1, 2025
• Primary Completion: February 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 15, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)