Sequential Anti-Angiogenic Therapy After Immunotherapy in Advanced Biliary Tract Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFirst Affiliated Hospital of Zhejiang University
About this trial
Brief Summary:
This study is for patients with advanced biliary tract cancer (cancer of the bile ducts or gallbladder). The purpose is to find out if using anti-blood vessel formation drugs after immunotherapy treatment can help patients live longer without their cancer getting worse.
What the study compares:
Control group: Patients receive standard chemotherapy as first-line treatment, then chemotherapy plus anlotinib (an anti-blood vessel drug) if their cancer progresses Treatment group: Patients receive chemotherapy plus immunotherapy as first-line treatment, then the same second-line treatment as the control group if their cancer progresses
Who can join:
Patients aged 18-75 with advanced biliary tract cancer that has been confirmed by tissue testing, who have not received immunotherapy or anti-blood vessel drugs before, and who are in good enough health for treatment.
What we want to learn:
The main goal is to see if patients who received immunotherapy first have better outcomes when they later receive anti-blood vessel treatment. We will measure how long patients live without their cancer getting worse during second-line treatment.
Study design:
This is a randomized study, meaning patients are assigned by chance to one of the two treatment groups. About 60 patients will participate across multiple hospitals in China. We will also collect blood and tissue samples to better understand how these treatments work.
The study will help doctors determine if this treatment sequence could become a new standard approach for patients with advanced biliary tract cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
PD-1/CTLA-4 Dual Functional Antibody
DrugPD-1/CTLA-4 Dual Functional Antibody (iparomlimab and tuvonralimab injection): 5 mg/kg intravenous infusion every 3 weeks (day 1 of each 21-day cycle) for up to 6 cycles, with potential for maintenance therapy continuation. Used in combination with GP regimen in experimental arm only. This is a novel dual-functional antibody targeting both PD-1 and CTLA-4 pathways simultaneously.
Gemcitabine, Cisplatin
DrugGemcitabine 1000 mg/m² d1,8+Cisplatin 25mg/m² d1,8
Anlotinib
Drug10mg po d1-14 q3w
Oxaliplatin + 5-Fluorouracil/Leucovorin
DrugXELOX (oxaliplatin 130mg/m² d1+capecitabine 1000mg/m² d1-14 q3w) or FOLFOX6 (Oxaliplatin 85 mg/m², leucovorin 400 mg/m², fluorouracil 400 mg/m² intravenous bolus followed by fluorouracil 2400 mg/m² 46 hours, q2w)
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Standard Chemotherapy First-lineActive comparator 3 interventions
Group B: Immunotherapy Plus Chemotherapy First-lineExperimental treatment 4 interventions
Trial outcomes
Primary outcomes
1
Progression-Free Survival (PFS) of Second-Line Treatment
Progression-free survival defined as the time from initiation of second-line chemotherapy plus anlotinib treatment until radiographic disease progression per RECIST 1.1 criteria or death from any cause, whichever occurs first. Disease progression will be assessed by CT or MRI imaging every 2 treatment cycles (approximately every 6 weeks). This outcome measure specifically evaluates whether patients who received first-line immunotherapy plus chemotherapy have improved PFS during second-line anti-angiogenic treatment compared to patients who received first-line chemotherapy alone.
Time frame
From the start of second-line treatment until disease progression or death from any cause, assessed up to 24 monthsSponsors and contacts
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Source ClinicalTrials.gov