Radiotherapy Combined QL1706, TAS-102 and Bevacizumab in mCRC
ConditionmCRC
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJinan Central Hospital
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Palliative radiotherapy
- Iparomlimab and tuvonralimab
- TAS-102
- Bevacizumab
Treatment groups
37 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov