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
试验速览
- 阶段
- 3 期
- 入组人数
- 392
- 试验地点
- 17
- 主要终点
- Overall survival (OS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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;
- •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;
- •Cardiovascular abnormalities;
- •Gastrointestinal abnormalities;
- •History of immunodeficiency;
- •Has risk of bleeding;
- •Uncontrollable active bacterial, fungal or viral infections;
- •Lung diseases, such as interstitial pneumonia, obstructive lung disease, and history of symptomatic bronchospasm;
- •Allergies to the ingredients of the study drug;
- •Have a history of neurological or psychiatric disorders
- •According to the researcher's point of view, other severe, acute or chronic medical or mental illnesses or laboratory abnormalities that may increase the risks associated with participating in the study, or may interfere with the interpretation of the study results;
- •Have a history of pituitary or adrenal dysfunction
- •Has received major surgical treatment, open biopsy, or obvious traumatic injury within 28 days before the first administration;
- •Long-term unhealed wound or fracture;
- •Has drug abuse history that unable to abstain from or mental disorders;
- •Has participated in other clinical trials within 30 days before the study.
- •Has vaccinated with vaccines or attenuated vaccines within 4 weeks prior to first administration.
- •Pregnant or breastfeeding women.
- •According to the judgement of the investigators, there are other factors that may lead to the termination of the study.
研究组 & 干预措施
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).
干预措施: TQB2450 Injection (Drug)
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).
干预措施: Anlotinib hydrochloride (Drug)
Chemotherapy
Capecitabine tablets combined with oxaliplatin injection or gemcitabine hydrochloride injection. Each cycle is 3 weeks.
干预措施: Oxaliplatin injection (Drug)
Chemotherapy
Capecitabine tablets combined with oxaliplatin injection or gemcitabine hydrochloride injection. Each cycle is 3 weeks.
干预措施: Capecitabine tablets (Drug)
Chemotherapy
Capecitabine tablets combined with oxaliplatin injection or gemcitabine hydrochloride injection. Each cycle is 3 weeks.
干预措施: Gemcitabine hydrochloride injection (Drug)
结局指标
主要结局
Overall survival (OS)
时间窗: 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.
次要结局
- 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)