| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| 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 |
|---|---|
|
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.
|
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
|
|
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.
|
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
|
| 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 | |||||
|---|---|---|---|---|---|
| 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 | ||||
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* 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 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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