A Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule as Second-line Treatment in Subjects With Advanced Biliary Cancer

March 19, 2021 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

392

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230001
    • Beijing
      • Beijing, Beijing, China, 100044
        • Not yet recruiting
        • Peking University People's Hospital
        • Contact:
        • Principal Investigator:
          • Lei Chen, Doctor
      • Beijing, Beijing, China, 100021
        • Not yet recruiting
        • Cancer Hospital Chinese Academy of Medical Sciences
        • Principal Investigator:
          • Aiping Zhou, Doctor
        • Contact:
      • Beijing, Beijing, China, 102218
        • Not yet recruiting
        • Beijing Tsinghua Changgung Hospital
        • Contact:
        • Principal Investigator:
          • Jiahong Dong, Doctor
      • Beijing, Beijing, China, 100089
        • Recruiting
        • Beijing Cancer Hospital
      • Beijing, Beijing, China, 100020
        • Not yet recruiting
        • Beijing Chao-Yang Hospital,Capital medical university
        • Contact:
        • Principal Investigator:
          • Guangyu An, Doctor
      • Beijing, Beijing, China, 100069
        • Not yet recruiting
        • Beijing Youan Hospital,Captical Medical University
        • Contact:
        • Principal Investigator:
          • Dondong Lin, Doctor
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Not yet recruiting
        • Fujian Medical University Union Hospital
        • Contact:
    • Hebei
      • Baoding, Hebei, China, 071000
        • Not yet recruiting
        • Affiliated Hospital of Hebei University
        • Principal Investigator:
          • Aimin Zang, master
        • Contact:
      • Cangzhou, Hebei, China, 061001
        • Not yet recruiting
        • Cangzhou Central Hospital
        • Contact:
        • Principal Investigator:
          • Jinghua Gao, bachelor
      • Chengde, Hebei, China, 067000
        • Not yet recruiting
        • Affiliated Hospital of Chengde Medical University
        • Contact:
        • Principal Investigator:
          • Qingshan Li, bachelor
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Not yet recruiting
        • Harbin medical university affiliated tumor hospital
        • Principal Investigator:
          • Yanqiao Zhang, Doctor
        • Contact:
    • Henan
      • Zhengzhou, Henan, China, 450003
        • Not yet recruiting
        • Henan Tumor Hospital
        • Contact:
        • Principal Investigator:
          • Xiaobing Chen, Doctor
    • Hubei
      • Wuhan, Hubei, China, 430040
        • Not yet recruiting
        • Tongji Medical College of Hust
        • Contact:
        • Principal Investigator:
          • Hong Qiu, Doctor
    • Hunan
      • Changsha, Hunan, China, 410000
        • Not yet recruiting
        • Hunan Provincial People's Hospital
        • Contact:
        • Principal Investigator:
          • Chuang Peng, Doctor
    • Jiangsu
      • Changzhou, Jiangsu, China, 213000
        • Not yet recruiting
        • The First Peoples Hospital of Changzhou
        • Contact:
        • Principal Investigator:
          • Haijiao Yan, Doctor
    • Jilin
      • Changchun, Jilin, China, 130000
        • Not yet recruiting
        • The First Bethune Hospital of Jilin University
        • Contact:
        • Principal Investigator:
          • Wei Li, Doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:
    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:
    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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
Drug: TQB2450 Injection
TQB2450 1200 mg administered intravenously (IV) on Day 1 of each 21-day cycle.
Drug: Anlotinib hydrochloride
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).
Active Comparator: Chemotherapy
Capecitabine tablets combined with oxaliplatin injection or gemcitabine hydrochloride injection. Each cycle is 3 weeks.
Drug: Oxaliplatin injection
Oxaliplatin injection 130 mg/m2 administered IV on Day 1 of each week in 3-week cycles;
Drug: Capecitabine tablets
Capecitabine tablets total dose 2000 mg/m2, oral twice a day from Day 1-14 of each 3- week cycles;
Drug: Gemcitabine hydrochloride injection
Gemcitabine hydrochloride injection administered 1000 mg/m2 IV on Day 1 and Day 8 of each week in 3-week cycles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 40 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival at 12 months
Time Frame: up to 12 months
Percentage of participants whose OS has achieved at least 12 months.
up to 12 months
Progression free survival (PFS)
Time Frame: up to 24 weeks
PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.
up to 24 weeks
Overall response rate (ORR)
Time Frame: up to 24 weeks
Percentage of participants achieving complete response (CR) and partial response (PR).
up to 24 weeks
Disease control rate（DCR）
Time Frame: up to 24 weeks
Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).
up to 24 weeks
Duration of response（DOR）
Time Frame: up to 24 weeks
The time when the participants first achieved complete or partial remission to disease progression.
up to 24 weeks
Progression-free survival at 6 months
Time Frame: up to 6 months
Percentage of participants whose PFS has achieved at least 6 months.
up to 6 months
Overall survival at 6 months
Time Frame: up to 6 months
Percentage of participants whose OS has achieved at least 6 months.
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 4, 2021

Primary Completion (Anticipated)

March 18, 2022

Study Completion (Anticipated)

February 1, 2023

Study Registration Dates

First Submitted

March 19, 2021

First Submitted That Met QC Criteria

March 19, 2021

First Posted (Actual)

March 22, 2021

Study Record Updates

Last Update Posted (Actual)

March 22, 2021

Last Update Submitted That Met QC Criteria

March 19, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TQB2450-III-08

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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