NCT07116577Not yet recruitingPhase 2
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 · Last updated 11 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 37 (estimated)
- First submitted
- 6 Aug 2025
- Start date
- 31 Aug 2025
- Primary completion date
- 31 Aug 2027
- Lead sponsor
- Jinan Central Hospital
- Diseases
- Colorectal cancer
- NCT number
- NCT07116577
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 37
- From 31 Aug 2025 to the primary completion date, 31 Aug 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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 cardiovascular/cerebrovascular diseases.
- Medical/social conditions that may compromise study results or lead to premature termination per investigator judgment.
Other
- Uncontrolled or symptomatic serous cavity effusions (pleural, ascites, pericardial).
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Jinan Central Hospital Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.