A Single-Arm, Exploratory Study of Palliative Radiotherapy Combined With Iparomlimab and Tuvonralimab, Trifluridine/Tipiracil (TAS-102), and Bevacizumab in Later-Line Treatment of Advanced Colorectal Cancer
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Jinan Central Hospital
- Enrollment
- 37
- Locations
- 1
- Primary Endpoint
- ORR
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Experimental Arm
Palliative radiotherapy combined with iparomlimab and tuvonralimab (QL1706), trifluridine/tipiracil (TAS-102), and bevacizumab.
Intervention: Palliative radiotherapy (Radiation)
Experimental Arm
Palliative radiotherapy combined with iparomlimab and tuvonralimab (QL1706), trifluridine/tipiracil (TAS-102), and bevacizumab.
Intervention: Iparomlimab and tuvonralimab (Drug)
Experimental Arm
Palliative radiotherapy combined with iparomlimab and tuvonralimab (QL1706), trifluridine/tipiracil (TAS-102), and bevacizumab.
Intervention: TAS-102 (Drug)
Experimental Arm
Palliative radiotherapy combined with iparomlimab and tuvonralimab (QL1706), trifluridine/tipiracil (TAS-102), and bevacizumab.
Intervention: Bevacizumab (Drug)
Outcomes
Primary Outcomes
ORR
Time Frame: 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 Outcomes
- 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.)
Investigators
Meili Sun
Director of Department of Oncology
Jinan Central Hospital