Radiotherapy Combined QL1706, TAS-102 and Bevacizumab in mCRC

NCT07116577 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: 20250710004
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

mCRC

Outcome Measures

Primary Outcomes (1)

• ORR

  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.

  approximately 4 months after the last subject participating in

Secondary Outcomes (4)

• PFS

  approximately 12 months after the last subject participating in

• OS

  approximately 12 months after the last subject participating in

• DCR

  approximately 4 months after the last subject participating in

• Safety (adverse event)

  Up to approximately 2 years.

Study Arms (1)

Experimental Arm

EXPERIMENTAL

Palliative radiotherapy combined with iparomlimab and tuvonralimab (QL1706), trifluridine/tipiracil (TAS-102), and bevacizumab.

Radiation: Palliative radiotherapy; Drug: Iparomlimab and tuvonralimab; Drug: TAS-102; Drug: Bevacizumab

Interventions

Palliative radiotherapy RADIATION

Conventional fractionation, low-dose hypofractionated radiotherapy, or high-dose hypofractionated radiotherapy may be employed.

Experimental Arm

Iparomlimab and tuvonralimab DRUG

5 mg/kg, intravenously infused on Day 1 of each cycle, administered every 3 weeks (with each cycle defined as 21 days).

Experimental Arm

TAS-102 DRUG

35 mg/m², orally twice daily on Days 1 to 5 and Days 8 to 12 of each cycle, with each cycle spanning 28 days (4 weeks).

Experimental Arm

Bevacizumab DRUG

7.5 mg/kg via intravenous infusion on Day 1 of each 21-day cycle.

Experimental Arm

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jinan Central Hospital: lead

Study Sites (1)

Jinan Central Hospital

Jinan, Shandong, 250000, China

Location

MeSH Terms

Interventions

trifluridine tipiracil drug combination; Bevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Meili Sun, Director, Department of Oncology, MD, PhD,

  Jinan Central Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yawen Zhen, Associate Director, Department of Oncology

CONTACT

+86 150 2001 0760; my123454321@126.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: Director of Department of Oncology

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: August 11, 2025
• Study Start: August 31, 2025
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 11, 2025

Record last verified: 2025-08

Locations

CN (1)