OncoMatch/Clinical Trials/NCT07854600
A Phase II Study of Ivonescimab in Combination With GEMOX as Neoadjuvant and Conversion Therapy for Biliary Tract Cancer
Official title: A Single-Arm, Multi-Cohort, Phase II Study of Ivonescimab in Combination With GEMOX Chemotherapy as Neoadjuvant and Conversion Therapy for Biliary Tract Cancer
Is NCT07854600 recruiting? Yes, currently enrolling (Oct 2026). This Phase 2 trial studies multiple treatments including Ivonescimab and GEMOX Regimen for biliary tract cancer (btc).
Treatment: Ivonescimab · GEMOX Regimen — The purpose of this study is to explore the efficacy and safety of Ivonescimab in combination with GEMOX chemotherapy as neoadjuvant and conversion therapy for patients with biliary tract cancer. It aims to evaluate the impact of this combination regimen on postoperative recurrence, patient survival, and medication safety. This is a single-center, phase II, interventional, single-arm, multi-cohort clinical study. A total of 87 eligible participants will be enrolled and assigned to either the neoadjuvant therapy cohort (45 participants) or the conversion therapy cohort (42 participants).
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Other
Cancer type
Cholangiocarcinoma
Disease stage
Required: Stage IIIA OR HIGHER LESIONS ACCORDING TO THE 8TH EDITION OF THE AJCC STAGING SYSTEM (other)
radiologically assessed as locally advanced or with oligometastases (defined as Stage IIIA or higher lesions according to the 8th edition of the AJCC staging system)
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: systemic anti-tumor therapy for BTC
No prior systemic therapy for biliary tract cancer
Cannot have received: gemcitabine-based chemotherapy
Prior treatment with gemcitabine-based chemotherapy
Cannot have received: platinum-based chemotherapy
Prior treatment with ... platinum-based chemotherapy
Cannot have received: tumor immunotherapy
Prior treatment with ... any tumor immunotherapy/targeted therapy (e.g., PD-1/PD-L1 inhibitors, VEGF inhibitors, etc.)
Cannot have received: targeted therapy
Prior treatment with ... any tumor immunotherapy/targeted therapy (e.g., PD-1/PD-L1 inhibitors, VEGF inhibitors, etc.)
Lab requirements
Blood counts
ANC >= 1.5 x 10^9/L, platelet count >= 90 x 10^9/L, hemoglobin >= 90 g/L; Hemoglobin > 9 g/dL without blood transfusion or use of erythropoietin within the past 14 days
Kidney function
Serum creatinine <= 1.5 x ULN and creatinine clearance rate >= 60 ml/min
Liver function
Child-Pugh class A liver function; AST and ALT <= 3 x ULN; TBil <= 1.5 x ULN
Cardiac function
Myocardial enzyme spectrum within the normal range; ECG QTc (Fridericia) <= 450 ms; INR <= 1.2 or PT <= 1.2 x ULN; good coagulation function
Child-Pugh class A liver function. Normal bone marrow, liver, and kidney function, meeting the following clinical laboratory evaluation criteria within 7 days prior to treatment ... Myocardial enzyme spectrum within the normal range ... ECG QTc (Fridericia) <= 450 ms
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07854600 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
What disease stage is eligible?
Stage IIIA OR HIGHER LESIONS ACCORDING TO THE 8TH EDITION OF THE AJCC STAGING SYSTEM is required.
Is there an age limit?
Yes. Patients must be 80 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages