A Randomized, Open-label, Parallel Controlled, Multi-center Phase III Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule Versus Chemotherapy as Second-line Treatment in Subjects With Advanced Biliary Cancer
Overview
- Phase
- Phase 3
- Intervention
- TQB2450 Injection
- Conditions
- Advanced Biliary Cancer
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Enrollment
- 392
- Locations
- 17
- Primary Endpoint
- Overall survival (OS)
- Last Updated
- 5 years ago
Overview
Brief Summary
This study is a randomized, parallel controlled, multicentre phase III clinical trial to evaluate the efficacy and safety of TQB2450 combined with anlotinib versus chemotherapy as second-line treatment in subjects with advanced biliary cancer.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically or cytologically confirmed biliary adenocarcinoma, including intrahepatic cholangiocarcinoma (ICC), extrahepatic cholangiocarcinoma (ECC) and gallbladder cancer (GBC).
- •2.18 years and older,Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months;Weight ≥40 kg or BMI ≥18.
- •At least one measurable lesion (based on RECIST 1.1).
- •Previous first-line gemcitabine or fluorouracil-based combination chemotherapy failed.
- •5.Adequate laboratory indicators.
- •No pregnant or breastfeeding women, and a negative pregnancy test.
- •Understood and Signed an informed consent form.
Exclusion Criteria
- •Tumor disease and medical history:
- •Has central nervous system metastases (CNS) and/or cancerous meningitis or leptomeningeal carcinomatosis;
- •Has other malignant tumors within 5 years;
- •Imaging (CT or MRI) shows that tumor invades large blood vessels or the boundary with blood vessels is unclear;
- •Severe bone damage caused by tumor bone metastasis;
- •Has uncontrolled and repeated drainage pleural effusion, pericardial effusion, and ascites;
- •Partial or complete intestinal obstruction and complete biliary obstruction that cannot be relieved;
- •Previous anti-tumor therapy:
- •Has received Anlotinib Hydrochloride Capsules, Bevacizumab Injection, and immune checkpoint inhibitors such as PD-1, PD-L1, and CTLA-4 in prior treatment;
- •Have received anti-tumor therapy within 4 weeks before the first administration;
Arms & Interventions
TQB2450+Anlotinib
TQB2450 1200 mg administered intravenously (IV) on Day 1 of each 21-day cycle ,Anlotinib capsules 12 mg given orally, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21).
Intervention: TQB2450 Injection
TQB2450+Anlotinib
TQB2450 1200 mg administered intravenously (IV) on Day 1 of each 21-day cycle ,Anlotinib capsules 12 mg given orally, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21).
Intervention: Anlotinib hydrochloride
Chemotherapy
Capecitabine tablets combined with oxaliplatin injection or gemcitabine hydrochloride injection. Each cycle is 3 weeks.
Intervention: Oxaliplatin injection
Chemotherapy
Capecitabine tablets combined with oxaliplatin injection or gemcitabine hydrochloride injection. Each cycle is 3 weeks.
Intervention: Capecitabine tablets
Chemotherapy
Capecitabine tablets combined with oxaliplatin injection or gemcitabine hydrochloride injection. Each cycle is 3 weeks.
Intervention: Gemcitabine hydrochloride injection
Outcomes
Primary Outcomes
Overall survival (OS)
Time Frame: up to 40 weeks
OS defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.
Secondary Outcomes
- Overall response rate (ORR)(up to 24 weeks)
- Duration of response（DOR）(up to 24 weeks)
- Progression free survival (PFS)(up to 24 weeks)
- Disease control rate（DCR）(up to 24 weeks)
- Overall survival at 6 months(up to 6 months)
- Overall survival at 12 months(up to 12 months)
- Progression-free survival at 6 months(up to 6 months)