Condition or disease | Intervention/treatment | Phase |
---|---|---|
Advanced Solid Tumor | Drug: Anlotinib Drug: pd-1 antibody | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Exploratory Clinical Study on the Second-line and Above Treatment of Advanced Solid Tumor With Anlotinib Hydrochloride Combined With Pd-1 Antibody: An Open-Label, Single-center, Single-arm Study |
Actual Study Start Date : | April 8, 2019 |
Estimated Primary Completion Date : | June 8, 2020 |
Estimated Study Completion Date : | July 8, 2021 |
Arm | Intervention/treatment |
---|---|
Experimental: Anlotinib&pd-1 antibody
Anlotinib 10mg/d,q.d.,p.o.&pd-1 antibody 200mg/d.q.3w.d.l.v
|
Drug: Anlotinib
Anlotinib Hydrochloride Capsules
Other Name: Fu ke wei
Drug: pd-1 antibody Pembrolizumabinjection
Other Name: Keytruda
|
Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Zibing Wang | 18937621301 | bingziwang@hotmail.com |
China, Henan | |
Henan Cancer Hospital | Recruiting |
Zhengzhou, Henan, China, 450008 | |
Contact: Zibing Wang |
Principal Investigator: | Zibing Wang | Henan Cancer Hospital |
Tracking Information | |||||
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First Submitted Date ICMJE | May 23, 2019 | ||||
First Posted Date ICMJE | June 5, 2019 | ||||
Last Update Posted Date | June 5, 2019 | ||||
Actual Study Start Date ICMJE | April 8, 2019 | ||||
Estimated Primary Completion Date | June 8, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Progression-free Survival (PFS) [ Time Frame: up to 2 year ] From date of randomization until the date of first documented progression or date of death from any cause
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE |
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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 | Clinical Study on the Second-line and Above Treatment of Advanced Solid Tumor With Anlotinib Combined With Pd-1 Antibody | ||||
Official Title ICMJE | Exploratory Clinical Study on the Second-line and Above Treatment of Advanced Solid Tumor With Anlotinib Hydrochloride Combined With Pd-1 Antibody: An Open-Label, Single-center, Single-arm Study | ||||
Brief Summary | The main objective was to evaluate the safety and efficacy of anlotinib hydrochloride combined with pd-1 antibody second-line and above in the treatment of advanced solid tumors | ||||
Detailed Description | To observe the beneficial population and adverse reactions of anlotinib hydrochloride combined with pd-1 in the treatment of patients with advanced solid tumor, and to explore the safe and effective drug treatment dose in the combined program, so that more patients with advanced tumor with poor prognosis can benefit from the combined program | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 Phase 3 |
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Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Advanced Solid Tumor | ||||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: Anlotinib&pd-1 antibody
Anlotinib 10mg/d,q.d.,p.o.&pd-1 antibody 200mg/d.q.3w.d.l.v
Interventions:
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
100 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | July 8, 2021 | ||||
Estimated Primary Completion Date | June 8, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | China | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03975036 | ||||
Other Study ID Numbers ICMJE | 2019093 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Henan Cancer Hospital | ||||
Study Sponsor ICMJE | Henan Cancer Hospital | ||||
Collaborators ICMJE | Cttq | ||||
Investigators ICMJE |
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PRS Account | Henan Cancer Hospital | ||||
Verification Date | January 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |