Radiotherapy Combined QL1706, TAS-102 and Bevacizumab in mCRC

Not Applicable

Not yet recruiting

• Conditions: mCRC
• Interventions: Radiation: Palliative radiotherapy; Drug: Iparomlimab and tuvonralimab; Drug: TAS-102; Drug: Bevacizumab

• Registration Number: NCT07116577
• Lead Sponsor: Jinan Central Hospital

Brief Summary

This single-center, single-arm, prospective study plans to enroll patients with advanced colorectal cancer who have failed first-line or higher systemic therapies. Participants will receive a combination of iparomlimab and tuvonralimab (QL1706), trifluridine/tipiracil (TAS-102), bevacizumab, and palliative radiotherapy. The efficacy and safety of this combination therapy will be evaluated by assessing objective response rate (ORR), progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and safety profile.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-06
• Study First Submitted QC: 2025-08-06
• Last Update Submitted: 2025-08-06
• Study First Posted: 2025-08-11
• Last Update Posted: 2025-08-11
• Study Start: 2025-08-31
• Primary Completion: 2027-08-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

• Aged 18 to 75 years .
• Histologically confirmed unresectable colorectal adenocarcinoma.
• Patients must have received at least one prior line of oxaliplatin-, irinotecan-, or 5-FU-based therapy with documented progression or intolerance.
• Documented KRAS and BRAF mutation status (mutant or wild-type) must be available.
• Palliative radiotherapy targeting primary or metastatic lesions is planned.
• At least one measurable lesion per RECIST v1.1 exists.
• ECOG score of 0-1 and life expectancy ≥12 weeks.
• Adequate bone marrow, hepatic, and renal function must be demonstrated.
• Fertile patients commit to using effective contraception during and for 6 months post-treatment.

Exclusion Criteria

• History of Grade ≥3 immune-related adverse events (irAEs) from prior immunotherapy deemed contraindications for retreatment.
• Radiation or systemic anticancer therapy within 14 days prior to first study treatment.
• Active CNS metastases and/or leptomeningeal disease (LMD). Symptomatic interstitial lung disease (ILD), active pneumonitis, uncontrolled infections, or non-healing wounds/fistulae.
• Intestinal perforation risks: active diverticulitis, intra-abdominal abscess, GI obstruction, or cancer-related peritoneal carcinomatosis.
• Uncontrolled or symptomatic serous cavity effusions (pleural, ascites, pericardial).
• Uncontrolled cardiovascular/cerebrovascular diseases.
• Medical/social conditions that may compromise study results or lead to premature termination per investigator judgment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental Arm	Palliative radiotherapy	Palliative radiotherapy combined with iparomlimab and tuvonralimab (QL1706), trifluridine/tipiracil (TAS-102), and bevacizumab.
Experimental Arm	Iparomlimab and tuvonralimab	Palliative radiotherapy combined with iparomlimab and tuvonralimab (QL1706), trifluridine/tipiracil (TAS-102), and bevacizumab.
Experimental Arm	TAS-102	Palliative radiotherapy combined with iparomlimab and tuvonralimab (QL1706), trifluridine/tipiracil (TAS-102), and bevacizumab.
Experimental Arm	Bevacizumab	Palliative radiotherapy combined with iparomlimab and tuvonralimab (QL1706), trifluridine/tipiracil (TAS-102), and bevacizumab.

Primary Outcome Measures

Name	Time	Method
ORR	approximately 4 months after the last subject participating in	The time from the date for first documented response of complete response (CR) or partial response (PR) to the date of first documented of disease progression or death, whichever occurs first.

Secondary Outcome Measures

Name	Time	Method
PFS	approximately 12 months after the last subject participating in	the proportion of subjects with complete response (CR) and partial response (PR) according RESIST1.1 in total subjects.
OS	approximately 12 months after the last subject participating in	The time from the starting date of study drug to the date of death due to any cause.
DCR	approximately 4 months after the last subject participating in	The proportion of subjects with complete response (CR) and partial response (PR) and stable disease(SD) in total subjects
Safety (adverse event)	Up to approximately 2 years.	The rates of adverse events.

Trial Locations

Locations (1)

Jinan Central Hospital; 🇨🇳 Jinan, Shandong, China