Ovarian CancerPhase 3NCT07822646
A Phase 3 Study of Manganese-primed Immunochemotherapy in Patients With Advanced Ovarian Cancer
A Phase 3 study testing Manganese Chloride, Nab-paclitaxel and Platinum chemotherapy in people with Ovarian Cancer, run by Chinese PLA General Hospital at 6 sites in China.
Trial summary
Epithelial ovarian cancer is the most lethal gynecologic malignancy, and most patients eventually relapse and develop resistance to available therapies. Immune checkpoint inhibitors have shown limited overall efficacy in recurrent ovarian cancer, partly because of its immunosuppressive tumor microenvironment. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Manganese Chloride, Nab-paclitaxel and Platinum chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 6 sitesChina
- Study dates
- 12 Oct 2026to 20 Dec 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically or cytologically confirmed epithelial ovarian cancer, primary fallopian tube cancer, or peritoneal cancer.
- Patients who have received at least two prior lines of systemic therapy, including at least one platinum-based regimen.
- Patients who experienced disease progression during or within 6 months after completion of the most recent line of systemic therapy.
- Note: This most recent therapy is not required to be platinum-based and may be any systemic treatment (chemotherapy, targeted therapy, or other anticancer therapy).
- Patients with at least one measurable lesion.
- Patients who have received immunotherapy (anti-PD-1 antibodies, anti-PD-L1 antibodies), or bevacizumab, are not restricted from enrollment.
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- Expected survival of more than 6 months.
- Age over 18 years.
- Patient weight > 40 kg.
- ECOG performance status ≤ 2.
- Peripheral blood white blood cell count > 3.5×10 /L.
- Bone marrow reserve and liver and kidney function (the following laboratory tests should be performed before initial treatment to prove):
- Absolute neutrophil count (ANC) ≥ 1,000/mm ;
- Hemoglobin > 80 g/dL;
- Platelet count > 80,000/mm ;
- ALT/AST < 3×ULN;
- Serum creatinine < 3×ULN;
- Total bilirubin level < 3×ULN.
- No significant hereditary diseases.
- Normal liver and kidney biochemical indicators.
- Completed the last systemic anticancer therapy at least 4 weeks prior to enrollment, with resolution of all treatment-related adverse events to grade ≤1 according to NCI-CTCAE v5.0, with the exception of alopecia and other clinically insignificant toxicities deemed acceptable by the investigator.
- No treatment with paclitaxel (albumin-bound) plus platinum in the past 3 months.
- Voluntary participation and signing of informed consent, compliance with the trial treatment plan and visit schedule, and cooperation in observing adverse events and efficacy.
Who cannot join
- Absolute neutrophil count (ANC) < 1×10 /L or platelets < 80×10 /L or hemoglobin < 80 g/dL (according to the normal values of the clinical trial center）.
- Serum total bilirubin levels higher than 3 times the upper limit of the reference range.
- ALT, AST, or ALP levels higher than 3 times the upper limit of the reference range when there are no liver metastases; ALT, AST, or ALP levels higher than 5 times the upper limit of the reference range when there are liver metastases.
- Patients receiving known strong inhibitors (e.g., ketoconazole) or inducers (e.g., rifampicin or St. John's Wort) of CYP3A4, or strong inhibitors (e.g., gemfibrozil) or inducers of CYP2C8; patients receiving treatment with potent P-gp inhibitors or inducers, or patients who cannot stop treatment with these agents for 2 weeks before the start of the study.
- Subjects' bowel obstruction or requirement for bowel obstruction-related interventions within 3 weeks prior to first study drug administration; subjects with incomplete bowel obstruction who have returned to normal within 1 month before the first dose of the experimental drug can be included in the study after discussion by the researchers.
- Patients with severe or uncontrolled ascites, defined as either of the following: a) symptomatic ascites corresponding to CTCAE ≥ Grade 2; b) history of therapeutic paracentesis for ascites within 3 weeks prior to enrollment.
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- Organ failure:
- Heart: Grade III or IV.
- Liver: Grade C according to Child-Pugh B liver function classification.
- Kidney: Renal failure and uremia.
- Lung: Severe respiratory failure symptoms.
- Brain: Consciousness disorders.
- T-cell tumors such as T-cell lymphoma or T-cell leukemia.
- Major surgery within 4 weeks before enrollment, or planned major surgery during the study (excluding diagnostic surgery).
- HIV antibody positive, or other acquired, congenital immunodeficiency diseases, or patients with a history of organ transplantation.
- History of Parkinson's disease or epilepsy, or occurrence of diseases that can induce seizures within 12 months before the study (including a history of transient ischemic attack, stroke, traumatic brain injury with consciousness disorders).
- CTCAE grade 2 infections that do not respond to treatment or active clinically serious infections with CTCAE > Grade 2.
- Patients with active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection requiring treatment.
- Patients with a history of allergic reactions to study drug components or suspected allergies.
- Chronic diseases requiring immunotherapy or hormone therapy.
- Patients who have received any investigational drug treatment within 30 days before the first dose of the trial drug.
- Subjects with symptoms of brain or leptomeningeal metastasis.
- Subjects with a history of malignant tumors (non-study tumor) within 3 years before the first dose of the trial drug.
- History of the following diseases: interstitial lung disease, non-infectious pneumonia, or uncontrolled systemic diseases including diabetes, hypertension, pulmonary fibrosis, acute lung disease, abdominal infection, etc.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
Department of Obstetrics and Gynecology, Seventh Medical Center, Chinese PLA General Hospital
Beijing, Beijing Municipality, 100007
Wen Yang, +86-13810432069, rubyyangwen@sina.com
Wen Yang
- Recruiting
Department of Bio-therapeutic, First Medical Center, Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Weidong Han, +86-010-66937463, hanwdrsw@163.com
Qian Mei
- Recruiting
Department of Obstetrics and Gynecology, First Medical Center, Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Mingxia Ye, +86-15901229215, ymx298013@126.com
Mingxia Ye
- Not yet recruiting
Peking University International Hospital
Beijing, Beijing Municipality, 102206
Yuanguang Meng, +86-010-69006900, meng6512@vip.sina.com
Yuanguang Meng
- Not yet recruiting
Department of Gynecologic Oncology, Shanxi Province Cancer Hospital
Taiyuan, Shanxi, 030013
Hongwei Zhao, +86-0351-4651680, inmind20060829@126.com
- Not yet recruiting
Department of Obstetrics and Gynecology, North China University of Science and Technology Affiliated Hospital
Tangshan, Hebei, 063000
Yanfang He, +86-13011441189, heyanfang1979@sina.com
Yanfang He
About this study
Official title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Manganese-primed Immunochemotherapy in Subjects With Advanced Ovarian Cancer
Epithelial ovarian cancer is the most lethal gynecologic malignancy, and most patients eventually relapse and develop resistance to available therapies. Immune checkpoint inhibitors have shown limited overall efficacy in recurrent ovarian cancer, partly because of its immunosuppressive tumor microenvironment. Manganese (Mn2+) can activate the cGAS-STING pathway and may enhance antitumor immunity and the therapeutic effects of PD-1 blockade combined with chemotherapy. Following encouraging findings from an early-phase study, a randomized, single-blind, placebo-controlled phase II trial showed that the addition of manganese chloride to anti-PD-1 antibody, nab-paclitaxel, and cisplatin improved clinical outcomes compared with placebo, with an overall manageable safety profile. Based on these findings, this phase III trial is designed to confirm the efficacy and further evaluate the safety of Mn2+-primed immunochemotherapy in patients with advanced ovarian cancer.
- Conditions
- Ovarian Cancer
- Being tested
- Manganese Chloride, Nab-paclitaxel, Platinum chemotherapy, Anti-PD-1 antibody, Placebo
- Keywords
- Relapsed, Refractory, anti-PD-1 antibody, Manganese, Chemotherapy
- Medical subject headings
- Ovarian Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manganese ChlorideDrug
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
Nab-paclitaxelDrug
Administered intravenously, 180-220mg/m2 on day 2 in a 3-week cycle (day 1 without Manganese priming)
Platinum chemotherapyDrug
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)
Anti-PD-1 antibodyDrug
Administered intravenously, 200mg on day 3 in a 3-week cycle (day 2 without Manganese priming)
PlaceboDrug
Administered by inhalation twice per week in the first 3-week cycle, and then inhaled twice in the first week of each 3-week cycle thereafter
| Study group | Role | What they receive |
|---|---|---|
| Manganese primed anti-PD-1 plus nPP chemotherapy | Experimental | Subject received Manganese primed anti-PD-1 antibody, 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. Receives: Drug: Manganese Chloride; Drug: Nab-paclitaxel; Drug: Platinum chemotherapy; Drug: Anti-PD-1 antibody |
| anti-PD-1 plus nPP chemotherapy | Placebo comparator | Subject received placebo, anti-PD-1 antibody, 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. Receives: Drug: Nab-paclitaxel; Drug: Platinum chemotherapy; Drug: Anti-PD-1 antibody; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
PFS time was measured from study entry to the first documentation of disease progression or death. Disease progression was determined per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Measured: 12 months
Secondary outcomes (3)
Overall survival (OS)
OS time was measured from the study entry to the date of death.
Measured: 24 months
Object response rate (ORR)
ORR is defined as the proportion of subjects who achieved a partial response (PR) or complete response (CR) according to the RECIST V1.1.
Measured: 24 months
Number of Subjects with treatment-related adverse events (AEs)
Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0. AEs were considered to be treatment-related if they had started or worsened within the interval from first study drug administration until the follow-up visit.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start12 Oct 2026 (estimated)
- Primary completion12 Apr 2029 (estimated)
- Study completion20 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han weidong, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07822646
- Sponsor's protocol ID
- CHN-PLAGH-BT-101
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Manganese-primed Immunochemotherapy in Subjects With Advanced Ovarian Cancer
- ClinicalTrials.gov ID
- NCT07822646
- Acronym / sponsor ID
- CHN-PLAGH-BT-101
- Conditions
- Ovarian Cancer
- Keywords
- Relapsed, Refractory, anti-PD-1 antibody, Manganese, Chemotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 12 Oct 2026 (estimated)
- Primary completion
- 12 Apr 2029 (estimated)
- Study completion
- 20 Dec 2030 (estimated)
- First posted
- 16 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Epithelial ovarian cancer is the most lethal gynecologic malignancy, and most patients eventually relapse and develop resistance to available therapies. Immune checkpoint inhibitors have shown limited overall efficacy in recurrent ovarian cancer, partly because of its immunosuppressive tumor microenvironment. Manganese (Mn2+) can activate the cGAS-STING pathway and may enhance antitumor immunity and the therapeutic effects of PD-1 blockade combined with chemotherapy. Following encouraging findings from an early-phase study, a randomized, single-blind, placebo-controlled phase II trial showed that the addition of manganese chloride to anti-PD-1 antibody, nab-paclitaxel, and cisplatin improved clinical outcomes compared with placebo, with an overall manageable safety profile. Based on these findings, this phase III trial is designed to confirm the efficacy and further evaluate the safety of Mn2+-primed immunochemotherapy in patients with advanced ovarian cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manganese primed anti-PD-1 plus nPP chemotherapy | Experimental | Drug: Manganese Chloride, Drug: Nab-paclitaxel, Drug: Platinum chemotherapy, Drug: Anti-PD-1 antibodySubject received Manganese primed anti-PD-1 antibody, 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. |
| anti-PD-1 plus nPP chemotherapy | Placebo comparator | Drug: Nab-paclitaxel, Drug: Platinum chemotherapy, Drug: Anti-PD-1 antibody, Drug: PlaceboSubject received placebo, anti-PD-1 antibody, 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Patients with histologically or cytologically confirmed epithelial ovarian cancer, primary fallopian tube cancer, or peritoneal cancer.
- Patients who have received at least two prior lines of systemic therapy, including at least one platinum-based regimen.
- Patients who experienced disease progression during or within 6 months after completion of the most recent line of systemic therapy.
- Note: This most recent therapy is not required to be platinum-based and may be any systemic treatment (chemotherapy, targeted therapy, or other anticancer therapy).
- Patients with at least one measurable lesion.
Key exclusion criteria (24 listed)
- Absolute neutrophil count (ANC) < 1×10 /L or platelets < 80×10 /L or hemoglobin < 80 g/dL (according to the normal values of the clinical trial center）.
- Serum total bilirubin levels higher than 3 times the upper limit of the reference range.
- ALT, AST, or ALP levels higher than 3 times the upper limit of the reference range when there are no liver metastases; ALT, AST, or ALP levels higher than 5 times the upper limit of the reference range when there are liver metastases.
- Patients receiving known strong inhibitors (e.g., ketoconazole) or inducers (e.g., rifampicin or St. John's Wort) of CYP3A4, or strong inhibitors (e.g., gemfibrozil) or inducers of CYP2C8; patients receiving treatment with potent P-gp inhibitors or inducers, or patients who cannot stop treatment with these agents for 2 weeks before the start of the study.
- Subjects' bowel obstruction or requirement for bowel obstruction-related interventions within 3 weeks prior to first study drug administration; subjects with incomplete bowel obstruction who have returned to normal within 1 month before the first dose of the experimental drug can be included in the study after discussion by the researchers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manganese ChlorideAdministered 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 | Manganese primed anti-PD-1 plus nPP chemotherapy |
| Nab-paclitaxelAdministered intravenously, 180-220mg/m2 on day 2 in a 3-week cycle (day 1 without Manganese priming) | Drug | Manganese primed anti-PD-1 plus nPP chemotherapy, anti-PD-1 plus nPP chemotherapy |
| Platinum chemotherapyAdministered 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 | Manganese primed anti-PD-1 plus nPP chemotherapy, anti-PD-1 plus nPP chemotherapy |
| Anti-PD-1 antibodyAdministered intravenously, 200mg on day 3 in a 3-week cycle (day 2 without Manganese priming) | Drug | Manganese primed anti-PD-1 plus nPP chemotherapy, anti-PD-1 plus nPP chemotherapy |
| PlaceboAdministered by inhalation twice per week in the first 3-week cycle, and then inhaled twice in the first week of each 3-week cycle thereafter | Drug | anti-PD-1 plus nPP chemotherapy |
Primary outcome
Progression-free survival (PFS)
Time frame: 12 months
PFS time was measured from study entry to the first documentation of disease progression or death. Disease progression was determined per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
3 secondary outcomes
Overall survival (OS)
Time frame: 24 months
Object response rate (ORR)
Time frame: 24 months
Number of Subjects with treatment-related adverse events (AEs)
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Manganese Chloride, Nab-paclitaxel and Platinum chemotherapy in people with Ovarian Cancer, run by Chinese PLA General Hospital at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weidong Han (+86-01066937463, hanwdrsw@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.