| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Head and Neck Squamous Cell Cancer | Drug: Sintilimab and Nab-paclitaxel | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 41 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | An Exploratory Study of Sintilimab in Combination With Nab-paclitaxel in Patients With Advanced Recurrent or Metastatic HNSCC (Head and Neck Squamous Cell Carcinoma )After 2 or More Prior Lines of Therapy |
| Estimated Study Start Date : | July 20, 2019 |
| Estimated Primary Completion Date : | May 31, 2021 |
| Estimated Study Completion Date : | May 31, 2021 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Sintilimab in Combination With Nab-paclitaxe
Sintilimab 200 mg intravenous drip, first day Nab-paclitaxe120 mg/m2, intravenous drip, first day and eighth day
|
Drug: Sintilimab and Nab-paclitaxel
Sintilimab in Combination with Nab-paclitaxel in Patients with Advanced Recurrent or Metastatic HNSCC after 2 or More Prior Lines of Therapy
Other Name: IBI308
|
| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Women who were confirmed not to be pregnant within 7 days prior to the study were required to agree to take medically approved effective contraceptive measures throughout the trial period and within 6 months after the end of the trial. 19. Patients can follow up on schedule, communicate well with researchers and complete the study in accordance with the research requirements.
-
Exclusion Criteria:
| Contact: Shengyu ZHOU, doctor | 13520852899 | typhoonwho@126.com |
| China | |
| Department of Medical Oncology, Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College; Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs | |
| Beijing, China, 100021 | |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 21, 2019 | ||||
| First Posted Date ICMJE | June 5, 2019 | ||||
| Last Update Posted Date | July 18, 2019 | ||||
| Estimated Study Start Date ICMJE | July 20, 2019 | ||||
| Estimated Primary Completion Date | May 31, 2021 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
ORR [ Time Frame: 2 years ] Objective mitigation rate assessed by RECIST 1.1 standard
|
||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Sintilimab in Combination With Nab-paclitaxel in Patients With HNSCC (Head and Neck Squamous Cell Carcinoma ) | ||||
| Official Title ICMJE | An Exploratory Study of Sintilimab in Combination With Nab-paclitaxel in Patients With Advanced Recurrent or Metastatic HNSCC (Head and Neck Squamous Cell Carcinoma )After 2 or More Prior Lines of Therapy | ||||
| Brief Summary | Clinical studies related to immunotherapy of HNSCC have shown that PD1 monoclonal antibody has better clinical benefits than conventional chemotherapy. This phase II clinical study is a single arm, open, single-center study. The aim of this study is to observe and evaluate the efficacy and safety of Sintilimab combined with paclitaxel-albumin-binding for injection in patients with advanced recurrent and metastatic HNSCC who fail to receive first-line or more treatment. Participation in this study for treatment may benefit patients with advanced recurrence or metastasis of HNSCC. | ||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Phase 2 | ||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||||
| Condition ICMJE | Head and Neck Squamous Cell Cancer | ||||
| Intervention ICMJE | Drug: Sintilimab and Nab-paclitaxel
Sintilimab in Combination with Nab-paclitaxel in Patients with Advanced Recurrent or Metastatic HNSCC after 2 or More Prior Lines of Therapy
Other Name: IBI308
|
||||
| Study Arms ICMJE | Experimental: Sintilimab in Combination With Nab-paclitaxe
Sintilimab 200 mg intravenous drip, first day Nab-paclitaxe120 mg/m2, intravenous drip, first day and eighth day
Intervention: Drug: Sintilimab and Nab-paclitaxel
|
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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. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Unknown status | ||||
| Estimated Enrollment ICMJE |
41 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | May 31, 2021 | ||||
| Estimated Primary Completion Date | May 31, 2021 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||
| Sex/Gender ICMJE |
|
||||
| Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | China | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03975270 | ||||
| Other Study ID Numbers ICMJE | HNSCC-2LIOS-001 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | Shengyu Zhou, Chinese Academy of Medical Sciences | ||||
| Study Sponsor ICMJE | Shengyu Zhou | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| PRS Account | Chinese Academy of Medical Sciences | ||||
| Verification Date | June 2019 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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