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

  • STATUS
    Recruiting
  • End date
    Feb 1, 2023
  • participants needed
    392
  • sponsor
    Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Updated on 1 April 2021

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.

Details
Condition Advanced Biliary Cancer
Treatment Anlotinib Hydrochloride, TQB2450 injection, Capecitabine tablets, Oxaliplatin injection, Gemcitabine hydrochloride injection
Clinical Study IdentifierNCT04809142
SponsorChia Tai Tianqing Pharmaceutical Group Co., Ltd.
Last Modified on1 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

\. Histologically or cytologically confirmed biliary adenocarcinoma, including intrahepatic cholangiocarcinoma (ICC), extrahepatic cholangiocarcinoma (ECC) and gallbladder cancer (GBC)
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
\. 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

Exclusion Criteria

\. 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
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; 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
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
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