A Phase 3 interventional study of TQB2450 Injection and Anlotinib hydrochloride in Advanced Biliary Cancer, sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.. Status unknown at 17 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-22.
Sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Phase 3, Interventional, and Treatment
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.
484 studies on the registry are indexed under Biliary Tract Neoplasms; 187 are open to participants now.
This study's planned enrollment of 392 is above the median of 56 across 404 interventional studies indexed under Biliary Tract Neoplasms.
Browse Biliary Tract Neoplasms studies →Chia Tai Tianqing Pharmaceutical Group Co., Ltd. is the lead sponsor of 313 studies on the registry; 75 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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 ≥18.5.
5.Adequate laboratory indicators. 6. No pregnant or breastfeeding women, and a negative pregnancy test. 7. Understood and Signed an informed consent form.
Exclusion Criteria:
Tumor disease and medical history:
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Has drug abuse history that unable to abstain from or mental disorders; 4. Has participated in other clinical trials within 30 days before the study. 5. Has vaccinated with vaccines or attenuated vaccines within 4 weeks prior to first administration.
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).
Drug: TQB2450 Injection · Drug: Anlotinib hydrochloride
Capecitabine tablets combined with oxaliplatin injection or gemcitabine hydrochloride injection. Each cycle is 3 weeks.
Drug: Oxaliplatin injection · Drug: Capecitabine tablets · Drug: Gemcitabine hydrochloride injection
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.
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.
Time frame: up to 40 weeks
Progression free survival (PFS)
PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.
Time frame: up to 24 weeks
Overall response rate (ORR)
Percentage of participants achieving complete response (CR) and partial response (PR).
Time frame: up to 24 weeks
Disease control rate（DCR）
Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).
Time frame: up to 24 weeks
Duration of response（DOR）
The time when the participants first achieved complete or partial remission to disease progression.
Time frame: up to 24 weeks
Progression-free survival at 6 months
Percentage of participants whose PFS has achieved at least 6 months.
Time frame: up to 6 months
Overall survival at 6 months
Percentage of participants whose OS has achieved at least 6 months.
Time frame: up to 6 months
Overall survival at 12 months
Percentage of participants whose OS has achieved at least 12 months.
Time frame: up to 12 months
This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.