Radiotherapy Combined QL1706, TAS-102 and Bevacizumab in mCRC (NCT07116577) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Radiotherapy Combined QL1706, TAS-102 and Bevacizumab in mCRC
China37 participantsStarted 2025-08-31
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 termin…
What they're measuring
1
ORR
Timeframe: approximately 4 months after the last subject participating in
Trial details
NCT IDNCT07116577
SponsorJinan Central Hospital
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2027-08-31
Contact for this trial
Yawen Zhen, Associate Director, Department of Oncology