Radiotherapy Combined QL1706, TAS-102 and Bevacizumab in mCRC

Shandong First Medical University

Status and phase

Not yet enrolling

Phase 2

Conditions

mCRC

Treatments

Drug: Bevacizumab

Drug: Iparomlimab and tuvonralimab

Radiation: Palliative radiotherapy

Drug: TAS-102

Study type

Interventional

Funder types

Other

Identifiers

NCT07116577

20250710004

Details and patient eligibility

About

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.

Enrollment

37 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.