NCT03989336

A Study of the Pan-immunotherapy in Patients With Relapsed/Refractory Ovarian Cancer

Completed Phase 2 Last updated 15 July 2024

What this trial tests

Phase 2 trial testing Manganese Chloride in Ovarian Cancer in 84 participants. Completed in 10 December 2023.

Timeline

23 December 2020

Primary endpoint
22 May 2022

10 December 2023

Quick facts

Lead sponsor	Chinese PLA General Hospital
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	84
Start date	23 December 2020
Primary completion	22 May 2022
Estimated completion	10 December 2023
Sites	1 location across China

Drugs / interventions tested

• Manganese Chloride (MANGANESE CHLORIDE) — full drug profile →
• nab-paclitaxel (nab-paclitaxel) — full drug profile →
• Platinum chemotherapy — full drug profile →
• Sintilimab — full drug profile →

Conditions studied

• Ovarian Cancer — all drugs for Ovarian Cancer →

Sponsor

Chinese PLA General Hospital

Who can join

Adults 18 to 70, female only, with Ovarian Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Immunotherapy for Ovarian Cancer: Adjuvant, Combination, and Neoadjuvant.
   Yang C, Xia BR, Zhang ZC, Zhang YJ, et al · · 2020 · cited 246× · PMID 33123161 · DOI 10.3389/fimmu.2020.577869
2. Type I interferon-mediated tumor immunity and its role in immunotherapy.
   Yu R, Zhu B, Chen D. · · 2022 · cited 229× · PMID 35292881 · DOI 10.1007/s00018-022-04219-z
3. Tumor Microenvironment in Ovarian Cancer: Function and Therapeutic Strategy.
   Yang Y, Yang Y, Yang J, Zhao X, et al · · 2020 · cited 168× · PMID 32850861 · DOI 10.3389/fcell.2020.00758
4. Recent updates on Sintilimab in solid tumor immunotherapy.
   Liu X, Yi Y. · · 2020 · cited 35× · PMID 33292551 · DOI 10.1186/s40364-020-00250-z
5. Manganese-derived biomaterials for tumor diagnosis and therapy.
   Huang P, Tang Q, Li M, Yang Q, et al · · 2024 · cited 12× · PMID 38879519 · DOI 10.1186/s12951-024-02629-8
6. At the Crossroads of the cGAS-cGAMP-STING Pathway and the DNA Damage Response: Implications for Cancer Progression and Treatment.
   Korneenko TV, Pestov NB, Nevzorov IA, Daks AA, et al · · 2023 · cited 11× · PMID 38139802 · DOI 10.3390/ph16121675
7. Metallic nanomedicine in cancer immunotherapy.
   Li S, Wang X, Han H, Xiang S, et al · · 2025 · cited 2× · PMID 41049749 · DOI 10.1016/j.apsb.2025.07.017
8. Advancements in the utilization of immune checkpoint inhibitors for the treatment of gynecological tumors.
   Su Z, Zhang X, Xu J, Shen Y. · · 2026 · PMID 41983132 · DOI 10.3389/fimmu.2026.1686568