Condition or disease | Intervention/treatment | Phase |
---|---|---|
Advanced Cholangiocarcinoma | Drug: Anlotinib Drug: TQB2450 | Phase 1 Phase 2 |
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 |
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.
|
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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:
Contact: Lin Shen, Master | 010-88196340 | doctorshenlin@sina.cn |
China, Beijing | |
Beijing Cancer Hospital | Recruiting |
Beijing, Beijing, China, 100083 | |
Contact: Lin Shen, Master 010-88196340 doctorshenlin@sina.cn |
Tracking Information | |||||
---|---|---|---|---|---|
First Submitted Date ICMJE | June 21, 2019 | ||||
First Posted Date ICMJE | June 24, 2019 | ||||
Last Update Posted Date | October 30, 2019 | ||||
Actual Study Start Date ICMJE | June 24, 2019 | ||||
Estimated Primary Completion Date | December 31, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
|
||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
|
||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Study of TQB2450 Combined With Anlotinib in Subjects With Advanced Cholangiocarcinoma | ||||
Official Title ICMJE | Phase Ib Study to Evaluate the Pharmacokinetics, Safety and Efficacy of TQB2450 Injection(PD-L1 Antibody) Combined With Anlotinib in Subjects With Advanced Cholangiocarcinoma | ||||
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. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 Phase 2 |
||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||||
Condition ICMJE | Advanced Cholangiocarcinoma | ||||
Intervention ICMJE |
|
||||
Study Arms ICMJE | 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).
Interventions:
|
||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
42 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | March 31, 2022 | ||||
Estimated Primary Completion Date | December 31, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
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:
|
||||
Sex/Gender ICMJE |
|
||||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
|
||||
Listed Location Countries ICMJE | China | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03996408 | ||||
Other Study ID Numbers ICMJE | TQB2450-Ib-08 | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
|
||||
IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | ||||
Study Sponsor ICMJE | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | ||||
Verification Date | June 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |