A Clinical Study of Iparomlimab and Tuvonralimab Combined With Bevacizumab and Alternating Triweekly CAPOX/mCAPIRI Regimen as First-line Treatment for Unresectable Advanced Colorectal Cancer

NCT07446387 | Not Yet Recruiting Phase 2

• 1 other identifier: KY-2025-177
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a prospective, single-arm, multicenter exploratory clinical study aimed at evaluating the efficacy and safety of iparomlimab and tuvonralimab combined with bevacizumab and alternating triweekly CAPOX/mCAPIRI regimen as first-line treatment for unresectable advanced colorectal cancer. The study plans to enroll 70 patients with unresectable advanced metastatic colorectal cancer. After evaluation and confirmation of meeting enrollment criteria, patients will receive treatment with iparomlimab and tuvonralimab combined with bevacizumab and alternating triweekly CAPOX/mCAPIRI regimen. The primary endpoint of the study is ORR, and secondary endpoints include PFS, DoR, OS, and safety.

Conditions

Metastatic Colorectal Cancer (CRC)

Keywords

mCRC; bevacizumab; QL1706; Combination therapy; Alternating chemotherapy

Outcome Measures

Primary Outcomes (1)

• Investigator-assessed Objective Response Rate（ORR）

  CR+PR

  From enrollment to the end of treatment at 18 months

Secondary Outcomes (4)

• Investigator-assessed Progression-Free Survival（PFS）

  From enrollment to the end of treatment at 18 months

• Investigator-assessed Duration of Response（DoR）

  From enrollment to the end of treatment at 18 months

• Overall Survival（OS）

  From enrollment to the end of treatment at 36 months

• AE

  From enrollment to the end of treatment at 12 weeks

Study Arms (1)

QL1706+ bevacizumab+chemotherapy

EXPERIMENTAL

The study consists of a 6-cycle induction treatment phase and a maintenance treatment phase. During the induction phase, patients receive iparomlimab and tuvonralimab combined with bevacizumab and chemotherapy. During the maintenance phase, patients receive iparomlimab and tuvonralimab combined with bevacizumab and capecitabine until disease progression or intolerable toxicity.

Drug: Iparomlimab and tuvonralimab

Interventions

Iparomlimab and tuvonralimab DRUG

Induction Phase: Iparomlimab and tuvonralimab (5 mg/kg, Q3W, D1) + bevacizumab (7.5 mg/kg, Q3W, D1) + CAPOX regimen (oxaliplatin 130 mg/m², Q3W, D1; capecitabine 1,000 mg/m², BID, D1-14, Q3W) / mCAPIRI (irinotecan 180 mg/m², Q3W, D1; capecitabine 800 mg/m², BID, D1-14, Q3W) alternating every 42 days, assessed every 6 weeks, for a maximum of 6 cycles. Maintenance Phase: Iparomlimab and tuvonralimab 5 mg/kg, Q3W, D1 + bevacizumab 7.5 mg/kg, Q3W, D1 + capecitabine 800-1,000 mg/m², BID, D1, Q3W. Patients with CR/PR/NED or SD are allowed to receive maintenance therapy until disease progression or intolerable toxicity.

QL1706+ bevacizumab+chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age 18-75 years;
• \. Patients with histologically or cytologically confirmed unresectable, advanced colorectal cancer;
• \. No prior systemic treatment;
• \. ECOG PS score ≤2;
• \. Expected survival ≥3 months;
• \. MSS/MSI-L status;
• \. At least one evaluable lesion based on RECIST 1.1 criteria;
• \. No prior systemic chemotherapy or other systemic therapy, or only received adjuvant chemotherapy with disease progression or recurrence within 6 months after completion of treatment;
• \. Adequate organ function reserve, with specific hepatic, renal, and hematologic parameters as follows:
• White blood cell count ≥3.5×10⁹/L
• Absolute neutrophil count ≥1.5×10⁹/L
• Hemoglobin ≥100 g/L
• Platelets ≥80×10⁹/L
• Serum liver enzymes ≤2.5× upper limit of normal (ULN) in patients without liver metastases
• Serum liver enzymes ≤5× ULN in patients with liver metastases

You may not qualify if:

• \. Prior hypersensitivity to any of the study drugs;
• \. Active or known or suspected autoimmune disease requiring systemic treatment, including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, thyroid dysfunction, asthma requiring bronchodilator intervention;
• \. Presence of non-measurable lesions (e.g., pleural effusion/ascites, carcinomatous lymphangitis, diffuse liver involvement, bone metastases);
• \. Pregnant or lactating women;
• \. Uncontrolled symptomatic brain metastases or psychiatric disorders preventing accurate expression of subjective symptoms;
• \. Vital organ function failure;
• \. Conditions affecting drug absorption/distribution/metabolism/excretion (e.g., seizures, central nervous system diseases, cognitive impairment due to psychiatric disorders, chronic diarrhea, cachexia, etc.);
• \. Patients with complete or incomplete intestinal obstruction;
• \. History of severe cardiac disease (including congestive heart failure, uncontrolled high-risk arrhythmia, angina requiring medication, definite valvular heart disease history, severe myocardial infarction, refractory hypertension);
• \. Active infection requiring systemic treatment;
• \. Known history of HIV infection;
• \. Known history of hepatitis B or active hepatitis C virus infection;
• \. Other conditions deemed unsuitable for enrollment by the investigator.

Sponsors & Collaborators

• Jiangsu Cancer Institute & Hospital: lead

Study Sites (1)

Jiangsu Cancer Hospital

Nanjing, Jiangsu, 210009, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Liangjun Zhu, Dr

  Jiangu Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liangjun Zhu

CONTACT

13505199123; zhulj98@foxmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician, Department of Medical Oncology

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 3, 2026
• Study Start (Estimated): May 30, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)