Palliative radiotherapy: Conventional fractionation, low-dose hypofractionated radiotherapy, or high-dose hypofractionated radiotherapy may be employed.
Iparomlimab and tuvonralimab: 5 mg/kg, intravenously infused on Day 1 of each cycle, administered every 3 weeks (with each cycle defined as 21 days).
TAS-102: 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).
Bevacizumab: 7.5 mg/kg via intravenous infusion on Day 1 of each 21-day cycle.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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