Clinical trial NCT04809142: A Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule as Second-line Treatment in Subjects With Advanced Biliary Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Advanced Biliary Cancer
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-03-22
Enrollment: 392
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 1. 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 ≥18.5.

3. At least one measurable lesion (based on RECIST 1.1). 4. Previous first-line gemcitabine or fluorouracil-based combination chemotherapy failed.

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:

* 1. Tumor disease and medical history:

  1. Has central nervous system metastases (CNS) and/or cancerous meningitis or leptomeningeal carcinomatosis;
  2. Has other malignant tumors within 5 years;
  3. Imaging (CT or MRI) shows that tumor invades large blood vessels or the boundary with blood vessels is unclear;
  4. Severe bone damage caused by tumor bone metastasis;
  5. Has uncontrolled and repeated drainage pleural effusion, pericardial effusion, and ascites;
  6. Partial or complete intestinal obstruction and complete biliary obstruction that cannot be relieved; 2. Previous anti-tumor therapy:

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  1. Has received Anlotinib Hydrochloride Capsules, Bevacizumab Injection, and immune checkpoint inhibitors such as PD-1, PD-L1, and CTLA-4 in prior treatment;
  2. Have received anti-tumor therapy within 4 weeks before the first administration;
  3. Unalleviated toxicity ≥ grade 1 due to any previous anticancer therapy; 3.Comorbidities and medical history:

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  1. Active hepatitis B or C;
  2. Kidney abnormalities;
  3. Abnormal thyroid function;
  4. Cardiovascular abnormalities;
  5. Gastrointestinal abnormalities;
  6. History of immunodeficiency;
  7. Has risk of bleeding;
  8. Uncontrollable active bacterial, fungal or viral infections;
  9. Lung diseases, such as interstitial pneumonia, obstructive lung disease, and history of symptomatic bronchospasm;
  10. Allergies to the ingredients of the study drug;
  11. Have a history of neurological or psychiatric disorders
  12. 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;
  13. Have a history of pituitary or adrenal dysfunction
  14. Has received major surgical treatment, open biopsy, or obvious traumatic injury within 28 days before the first administration;
  15. Long-term unhealed wound or fracture;
  16. 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.

      6. Pregnant or breastfeeding women. 7. According to the judgement of the investigators, there are other factors that may lead to the termination of the study.

Primary outcomes:
measure: Overall survival (OS)
timeFrame: up to 40 weeks
Secondary outcomes:
measure: Progression free survival (PFS)
timeFrame: up to 24 weeks
measure: Overall response rate (ORR)
timeFrame: up to 24 weeks
measure: Disease control rate（DCR）
timeFrame: up to 24 weeks
measure: Duration of response（DOR）
timeFrame: up to 24 weeks
measure: Progression-free survival at 6 months
timeFrame: up to 6 months
measure: Overall survival at 6 months
timeFrame: up to 6 months
measure: Overall survival at 12 months
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Provincal Hospital
state: Anhui
city: Beijing
country: China
facility: Beijing Chao-Yang Hospital,Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences
state: Beijing
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Youan Hospital,Captical Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Tsinghua Changgung Hospital
state: Beijing
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Baoding
country: China
facility: Affiliated Hospital of Hebei University
state: Hebei
city: Cangzhou
country: China
facility: Cangzhou Central Hospital
state: Hebei
city: Chengde
country: China
facility: Affiliated Hospital of Chengde Medical University
state: Hebei
city: Harbin
country: China
facility: Harbin Medical University Affiliated Tumor Hospital
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Tumor Hospital
state: Henan
city: Wuhan
country: China
facility: Tongji Medical College of HUST
state: Hubei
city: Changsha
country: China
facility: Hunan Provincial People's Hospital
state: Hunan
city: Changzhou
country: China
facility: The First Peoples Hospital of Changzhou
state: Jiangsu
city: Changchun
country: China
facility: The First Bethune Hospital of Jilin University
state: Jilin
Study officials:
References: