Condition or disease | Intervention/treatment | Phase |
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Ovarian Cancer | Drug: Manganese Chloride Drug: nab-paclitaxel Drug: Platinum chemotherapy Drug: Sintilimab | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 80 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase I/II, Open-label, Two-arm, Single-center Study to Evaluate the Safety and Efficacy of the Pan-immunotherapy in Subjects With Relapsed/Refractory Ovarian Cancer |
Actual Study Start Date : | June 20, 2019 |
Estimated Primary Completion Date : | May 31, 2021 |
Estimated Study Completion Date : | October 30, 2022 |
Arm | Intervention/treatment |
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Experimental: Manganese primed Sintilimab plus nPP chemotherapy
Subject received Manganese primed Sintilimab, nab-paclitaxel and platinum chemotherapy every 3 weeks until achieving a second assessable complete response or progressive disease, development of unacceptable toxicity, or withdrawal of consent.
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Drug: Manganese Chloride
Administered by inhalation at 0.4mg/kg twice per week in the first 3-week cycle, and then inhaled 0.4mg/kg twice in the first week of each 3-week cycle thereafter
Drug: nab-paclitaxel Administered intravenously, 180-220mg/m2 on day 2 in a 3-week cycle (day 1 without Manganese priming)
Other Name: Paclitaxel For Injection (Albumin Bound)
Drug: Platinum chemotherapy Administered intravenously, Cisplatin (60-80mg/m2) or Carboplatin (area under the curve [AUC] 4-6 mg/mL per min) on day 2 in a 3-week cycle (day 1 without Manganese priming)
Drug: Sintilimab Administered intravenously, 200mg on day 3 in a 3-week cycle (day 2 without Manganese priming)
Other Name: anti-PD-1 antibody; PD-1 inhibitor
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Active Comparator: Sintilimab plus nPP chemotherapy
Subject received Sintilimab, nab-paclitaxel and platinum chemotherapy every 3 weeks until achieving a second assessable complete response or progressive disease, development of unacceptable toxicity, or withdrawal of consent.
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Drug: nab-paclitaxel
Administered intravenously, 180-220mg/m2 on day 2 in a 3-week cycle (day 1 without Manganese priming)
Other Name: Paclitaxel For Injection (Albumin Bound)
Drug: Platinum chemotherapy Administered intravenously, Cisplatin (60-80mg/m2) or Carboplatin (area under the curve [AUC] 4-6 mg/mL per min) on day 2 in a 3-week cycle (day 1 without Manganese priming)
Drug: Sintilimab Administered intravenously, 200mg on day 3 in a 3-week cycle (day 2 without Manganese priming)
Other Name: anti-PD-1 antibody; PD-1 inhibitor
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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Weidong Han | 01066937463 | hanwdrsw@sina.com |
China, Beijing | |
Biotherapeutic Department of Chinese PLA General Hospital | Recruiting |
Beijing, Beijing, China, 100853 | |
Contact: Weidong Han, M.D +86-10-66937463 hanwdrsw@sina.com | |
Contact: Qingming Yang, M.D +86-10-55499341 yangqm301@163.com | |
Principal Investigator: Weidong Han, M.D | |
Principal Investigator: Qian Mei, M.D | |
Principal Investigator: Qingming Yang, M.D | |
Principal Investigator: Yan Zhang, M.S. | |
Sub-Investigator: Meixia Chen, M.S. | |
Sub-Investigator: Yuanguang Meng, M.D. | |
Sub-Investigator: Kaichao Feng, M.S. | |
Sub-Investigator: Yang Liu, M.D. | |
Sub-Investigator: Jiejie Liu, B.S. | |
Sub-Investigator: Xiang Li, B.S. | |
Sub-Investigator: Liang Dong, M.D. |
Tracking Information | |||||
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First Submitted Date ICMJE | June 15, 2019 | ||||
First Posted Date ICMJE | June 18, 2019 | ||||
Last Update Posted Date | December 22, 2020 | ||||
Actual Study Start Date ICMJE | June 20, 2019 | ||||
Estimated Primary Completion Date | May 31, 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | |||||
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 | An Open-label, Phase I/II Study of the Pan-immunotherapy in Patients With Relapsed/Refractory Ovarian Cancer | ||||
Official Title ICMJE | A Phase I/II, Open-label, Two-arm, Single-center Study to Evaluate the Safety and Efficacy of the Pan-immunotherapy in Subjects With Relapsed/Refractory Ovarian Cancer | ||||
Brief Summary | Ovarian cancer is the most lethal gynecological cancer and the 5th leading cause of cancer death in women. Platinum chemotherapy has been widely adopted as a standard treatment for advanced ovarian cancer, the response rates in patients with relapsed/refractory ovarian cancer is unacceptably low. PD-1 blockade has been developed to a new class of cancer immunotherapy that could restore an adequate immunosurveillance against the neoplasm and enhance T-cell-mediated anticancer immune responses. Manganese has been confirmed to activate antigen-presenting cells and function as mucosal immunoadjuvants in pre-clinical studies. This two-arm, phase I/II study is designed to assess the safety and efficacy of combined therapy of anti-PD-1 antibody and chemotherapy with or without Manganese priming. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Ovarian Cancer | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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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 |
80 | ||||
Original Estimated Enrollment ICMJE |
48 | ||||
Estimated Study Completion Date ICMJE | October 30, 2022 | ||||
Estimated Primary Completion Date | May 31, 2021 (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 | NCT03989336 | ||||
Other Study ID Numbers ICMJE | CHN-PLAGH-BT-040 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Han weidong, Chinese PLA General Hospital | ||||
Study Sponsor ICMJE | Chinese PLA General Hospital | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Chinese PLA General Hospital | ||||
Verification Date | December 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |