OncoMatch/Clinical Trials/NCT06335927
HAIC Combined With Cadonilimab and Regorafenib as 2nd-line Treatment for ICC
Is NCT06335927 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies HAIC-GEMOX+Cadonilimab+Regorafenib for intrahepatic cholangiocarcinoma.
Treatment: HAIC-GEMOX+Cadonilimab+Regorafenib — This study is a single-arm Phase II clinical trial aiming to evaluate the safety and efficacy of HAIC combined with Cadonilimab and Regorafenib as second-line treatment for unresectable intrahepatic cholangiocarcinoma. The study plans to enroll approximately 45 participants. All enrolled participants will receive continuous treatment: HAIC-Gemox: Gemcitabine 1000mg/m2 on Day 1 + Oxaliplatin 85mg/m2 on Day 1, every 3 weeks (Q3W), for up to 6 treatment cycles, Cadonilimab(6mg/kg, D2, Q3W) and Regorafenib (80mg QD, Q3W) until the investigator determines that there is no longer any clinical benefit (based on comprehensive assessment including RECIST v1.1 imaging evaluation and clinical condition), intolerable toxicity, initiation of new anti-tumor therapy, or meeting other criteria for treatment discontinuation, whichever occurs first.
Check if I qualifyExtracted eligibility criteria
Cancer type
Cholangiocarcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: standard treatment (gemcitabine plus cisplatin plus pembrolizumab, gemcitabine plus gemcitabine plus oxaliplatin, capecitabine plus oxaliplatin, chemotherapy mainly based on albumin-bound paclitaxel, 5-fluorouracil (5-FU) plus platinum-based therapy)
Patients who have failed standard treatment (standard treatment includes gemcitabine plus cisplatin plus pembrolizumab, gemcitabine plus gemcitabine plus oxaliplatin, capecitabine plus oxaliplatin, chemotherapy mainly based on albumin-bound paclitaxel, 5-fluorouracil (5-FU) plus platinum-based therapy) or are intolerant to standard treatment, or patients for whom standard treatment is not accessible.
Cannot have received: immune anti-tumor therapy
Previous receipt of any immune anti-tumor therapy, including immune checkpoint stimulants (e.g., ICOS, CD40, CD137, GITR, OX40 antibodies), immune cell therapy.
Cannot have received: targeted therapy
Previous receipt of targeted therapy.
Lab requirements
Blood counts
Absolute Neutrophil Count (ANC) ≥ 1.5 × 10^9/L (1,500/mm3). Platelet count ≥ 80 × 10^9/L (100,000/mm3). Hemoglobin ≥ 90 g/L.
Kidney function
Serum creatinine ≤ 1.5 × ULN. Calculated creatinine clearance (CrCl) ≥ 50 mL/min. Urine protein ≤ 1+ or 24-hour urinary protein quantification < 1.0 g.
Liver function
Total bilirubin (TBil) ≤ 3 × ULN. AST and ALT ≤ 5 × ULN. Serum albumin (ALB) ≥ 28 g/L.
Cardiac function
Left Ventricular Ejection Fraction (LVEF) ≥ 50%.
Adequate organ function determined by the following requirements: Hematology: ANC ≥ 1.5 × 10^9/L, Platelet count ≥ 80 × 10^9/L, Hemoglobin ≥ 90 g/L. Kidney: Serum creatinine ≤ 1.5 × ULN, CrCl ≥ 50 mL/min, Urine protein ≤ 1+ or 24-hour urinary protein quantification < 1.0 g. Liver: TBil ≤ 3 × ULN, AST and ALT ≤ 5 × ULN, ALB ≥ 28 g/L. Coagulation: INR and APTT ≤ 1.5 × ULN (unless on anticoagulant therapy and parameters are within expected range). Cardiac: LVEF ≥ 50%.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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