A Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule as Second-line Treatment in Subjects With Advanced Biliary Cancer
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
1 other identifier
interventional
392
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2021
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 4, 2021
CompletedFirst Submitted
Initial submission to the registry
March 19, 2021
CompletedFirst Posted
Study publicly available on registry
March 22, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 18, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2023
CompletedMarch 22, 2021
March 1, 2021
1.1 years
March 19, 2021
March 19, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Overall survival (OS)
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.
up to 40 weeks
Secondary Outcomes (7)
Progression free survival (PFS)
up to 24 weeks
Overall response rate (ORR)
up to 24 weeks
Disease control rate（DCR）
up to 24 weeks
Duration of response（DOR）
up to 24 weeks
Progression-free survival at 6 months
up to 6 months
- +2 more secondary outcomes
Study Arms (2)
TQB2450+Anlotinib
EXPERIMENTALTQB2450 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).
Chemotherapy
ACTIVE COMPARATORCapecitabine tablets combined with oxaliplatin injection or gemcitabine hydrochloride injection. Each cycle is 3 weeks.
Interventions
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).
Oxaliplatin injection 130 mg/m2 administered IV on Day 1 of each week in 3-week cycles;
Capecitabine tablets total dose 2000 mg/m2, oral twice a day from Day 1-14 of each 3- week cycles;
Gemcitabine hydrochloride injection administered 1000 mg/m2 IV on Day 1 and Day 8 of each week in 3-week cycles.
Eligibility Criteria
You may qualify if:
- \. Histologically or cytologically confirmed biliary adenocarcinoma, including intrahepatic cholangiocarcinoma (ICC), extrahepatic cholangiocarcinoma (ECC) and gallbladder cancer (GBC).
- years and older,Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months;Weight ≥40 kg or BMI ≥18.5.
- \. At least one measurable lesion (based on RECIST 1.1). 4. Previous first-line gemcitabine or fluorouracil-based combination chemotherapy failed.
- Adequate laboratory indicators. 6. No pregnant or breastfeeding women, and a negative pregnancy test. 7. Understood and Signed an informed consent form.
You may not qualify if:
- \. 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; 2. 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;
- Unalleviated toxicity ≥ grade 1 due to any previous anticancer therapy; 3.Comorbidities and medical history:
- <!-- -->
- Active hepatitis B or C;
- Kidney abnormalities;
- Abnormal thyroid function;
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Anhui Provincal Hospital
Hefei, Anhui, 230001, China
Beijing Chao-Yang Hospital,Capital Medical University
Beijing, Beijing Municipality, 100020, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021, China
Peking University People's Hospital
Beijing, Beijing Municipality, 100044, China
Beijing Youan Hospital,Captical Medical University
Beijing, Beijing Municipality, 100069, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100089, China
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, 102218, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001, China
Affiliated Hospital of Hebei University
Baoding, Hebei, 071000, China
Cangzhou Central Hospital
Cangzhou, Hebei, 061001, China
Affiliated Hospital of Chengde Medical University
Chengde, Hebei, 067000, China
Harbin Medical University Affiliated Tumor Hospital
Harbin, Heilongjiang, 150081, China
Henan Tumor Hospital
Zhengzhou, Henan, 450003, China
Tongji Medical College of HUST
Wuhan, Hubei, 430040, China
Hunan Provincial People's Hospital
Changsha, Hunan, 410000, China
The First Peoples Hospital of Changzhou
Changzhou, Jiangsu, 213000, China
The First Bethune Hospital of Jilin University
Changchun, Jilin, 130000, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2021
First Posted
March 22, 2021
Study Start
February 4, 2021
Primary Completion
March 18, 2022
Study Completion
February 1, 2023
Last Updated
March 22, 2021
Record last verified: 2021-03