Clinical trial · Interventional
Radiotherapy Combined QL1706, TAS-102 and Bevacizumab in mCRC
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| mCRC | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Iparomlimab and tuvonralimab | Drug | — | UNRESOLVED |
| Palliative radiotherapy | Radiation | — | UNRESOLVED |
| TAS-102 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental Arm
- description
- Palliative radiotherapy combined with iparomlimab and tuvonralimab (QL1706), trifluridine/tipiracil (TAS-102), and bevacizumab.
- interventionNames
- Radiation: Palliative radiotherapy
- Drug: Iparomlimab and tuvonralimab
- Drug: TAS-102
- Drug: Bevacizumab
Primary outcomes (1)
- measure
- ORR
- timeFrame
- approximately 4 months after the last subject participating in
- description
- 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 (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available