Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of TQB2450 Combined With Anlotinib in Subjects With Advanced Cholangiocarcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03996408
Recruitment Status : Recruiting
First Posted : June 24, 2019
Last Update Posted : October 30, 2019
Sponsor:
Information provided by (Responsible Party):
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Brief Summary:
TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors.

Condition or disease Intervention/treatment Phase
Advanced Cholangiocarcinoma Drug: Anlotinib Drug: TQB2450 Phase 1 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase Ib Study to Evaluate the Pharmacokinetics, Safety and Efficacy of TQB2450 Injection(PD-L1 Antibody) Combined With Anlotinib in Subjects With Advanced Cholangiocarcinoma
Actual Study Start Date : June 24, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Anlotinib + TQB2450
TQB2450 1200 mg IV on Day 1 of each 21-day cycle plus Anlotinib capsules given orally in fasting conditions , once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21).
Drug: Anlotinib
a multi-target receptor tyrosine kinase inhibitor

Drug: TQB2450
TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors.




Primary Outcome Measures :
  1. Dose limiting toxicity (DLT) [ Time Frame: up to 21 days ]
    DLT defined as any of the following events occurring during the study related to drugs : (1) ≥grade 3 non-hematologic toxicity; (2) Grade 4 neutropenia, thrombocytopenia, and hemoglobin reduction confirmed by at least 2 tests within 2 days; Grade 3 thrombocytopenia with bleeding tendency confirmed by at least 2 tests within 2 days; (3) Grade 3 neutropenia with fever confirmed at least 2 times within 2 days.

  2. Maximum tolerated dose (MTD) [ Time Frame: up to 21 days ]
    MTD defined as the highest dose level at which less than or equal to 2 of 6 subjects experience dose limiting toxicity (DLT)

  3. Recommended Phase II dose (RP2D) [ Time Frame: up to 24 months ]
    The RP2D defined as the lower dose level to MTD based on the safety profile

  4. Overall response rate (ORR) [ Time Frame: up to 24 months ]
    Percentage of subjects achieving complete response (CR) and partial response (PR)


Secondary Outcome Measures :
  1. Disease control rate(DCR) [ Time Frame: up to 24 months ]
    Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD)

  2. Progression-free survival (PFS) [ Time Frame: up to 24 months ]
    PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause

  3. Overall survival (OS) [ Time Frame: up to 24 months ]
    OS defined as the time from randomization to death from any cause. Subjects 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

  4. Adverse Event [ Time Frame: up to 24 months ]
    Number of participants with adverse events



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1.18 and 75 years; Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; Life expectancy ≥ 3 months.

2. Histologically or cytologically confirmed inoperable or metastatic cholangiocarcinoma.

3. Providing tumor specimen obtained by biopsy or surgical sample within 2 years.

4. At least one measurable lesion. 5. Has failed with standard first-line chemotherapy or were not suitable for standard first-line chemotherapy.

6.The main organs function are normally. 7. Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study (such as intrauterine devices , contraceptives or condoms) ;No pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the randomization.

8.Understood and signed an informed consent form.

Exclusion Criteria:

  1. Prior therapy with VEGFR-target TKI included anlotinib or an anti-programmed cell death (PD)-1, anti-PD-L1, anti-PD-L2, anti-tumor necrosis factor CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody ,or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
  2. Hypersensitivity to recombinant humanized anti-PD-1 monoclonal Abm or its components.
  3. Has diagnosed and/or treated additional malignancy within 5 years prior to randomization. Exceptions include cured basal cell carcinoma of skin and carcinoma in situ of cervix.
  4. Has any active autoimmune disease or a history of autoimmune disease.
  5. Has immunosuppressive therapy with systemic or absorbable topical hormone therapy and replacement therapy for hypothyroidism with normal thyroid function within 2 weeks before the first dose.
  6. Has multiple factors affecting oral medication.
  7. Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
  8. Has any signs of bleeding or a history of physical illness.
  9. Has uncontrollable symptoms of brain metastasis, spinal cord compression, cancerous meningitis during screening within 8 weeks before first dose.
  10. Has received chemotherapy, surgery, radiotherapy, the last treatment from the first dose less than 4 weeks, or oral targeted drugs for less than 5 half-lives, or oral fluorouracil pyridine drugs for less than 14 days, mitomycin C and nitrosourea for less than 6 weeks.
  11. Has any serious and / or uncontrolled disease.
  12. Has vaccinated with vaccines or attenuated vaccines, or received granulocyte colony stimulating factor(G -CSF),or Granulocyte macrophage colony stimulating factor (GM-CSF) within 4 weeks prior to first dose.
  13. According to the judgement of the researchers, there are other factors that may lead to the termination of the study. For example, other serious diseases including mental disorders need to be treated together, serious laboratory abnormalities, accompanied by family or social factors, which will affect the safety of the subjects, or the collection of data and samples.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03996408


Contacts
Layout table for location contacts
Contact: Lin Shen, Master 010-88196340 doctorshenlin@sina.cn

Locations
Layout table for location information
China, Beijing
Beijing Cancer Hospital Recruiting
Beijing, Beijing, China, 100083
Contact: Lin Shen, Master    010-88196340    doctorshenlin@sina.cn   
Sponsors and Collaborators
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Layout table for additonal information
Responsible Party: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
ClinicalTrials.gov Identifier: NCT03996408    
Other Study ID Numbers: TQB2450-Ib-08
First Posted: June 24, 2019    Key Record Dates
Last Update Posted: October 30, 2019
Last Verified: June 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Cholangiocarcinoma
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms