Can inhaled manganese make ovarian cancer immunotherapy hit harder?
NCT ID NCT07822646
First seen Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time
Summary
Researchers are testing whether adding inhaled manganese chloride to standard chemotherapy and an anti-PD-1 immunotherapy can help people with advanced ovarian cancer that has worsened after at least two prior treatments. The trial enrolls about 120 participants and randomly assigns them to receive either the manganese combination or a placebo alongside the same chemotherapy and immunotherapy. The main goal is to see whether the manganese combination lengthens the time before the cancer grows or the person dies.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Inhaled manganese chloride added to chemotherapy and an anti-PD-1 immunotherapy
- What this could lead to
- If it works, adding manganese to standard chemotherapy and immunotherapy could become a new way to treat ovarian cancer that has come back after earlier treatment.
- What could go wrong
- This is a phase 3 trial, so the approach is still experimental. Manganese priming may not improve outcomes, and combining it with chemotherapy and immunotherapy could add side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients with histologically or cytologically confirmed epithelial ovarian cancer, primary fallopian tube cancer, or peritoneal cancer. 2. Patients who have received at least two prior lines of systemic therapy, including at least one platinum-based regimen. 3. 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). 4. Patients with at least one measurable lesion. 5. Patients who have received immunotherapy (anti-PD-1 antibodies, anti-PD-L1 antibodies), or bevacizumab, are not restricted from enrollment. 6. Expected survival of more than 6 months. 7. Age over 18 years. 8. Patient weight \> 40 kg. 9. ECOG performance status ≤ 2. 10. Peripheral blood white blood cell count \> 3.5×10 /L. 11. 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. 12. No significant hereditary diseases. 13. Normal liver and kidney biochemical indicators. 14. 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. 15. No treatment with paclitaxel (albumin-bound) plus platinum in the past 3 months. 16. Voluntary participation and signing of informed consent, compliance with the trial treatment plan and visit schedule, and cooperation in observing adverse events and efficacy. Exclusion Criteria: 1. 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). 2. Serum total bilirubin levels higher than 3 times the upper limit of the reference range. 3. 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. 4. 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. 5. 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. 6. 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. 7. 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. 8. T-cell tumors such as T-cell lymphoma or T-cell leukemia. 9. Major surgery within 4 weeks before enrollment, or planned major surgery during the study (excluding diagnostic surgery). 10. HIV antibody positive, or other acquired, congenital immunodeficiency diseases, or patients with a history of organ transplantation. 11. 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). 12. CTCAE grade 2 infections that do not respond to treatment or active clinically serious infections with CTCAE \> Grade 2. 13. Patients with active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection requiring treatment. 14. Patients with a history of allergic reactions to study drug components or suspected allergies. 15. Chronic diseases requiring immunotherapy or hormone therapy. 16. Patients who have received any investigational drug treatment within 30 days before the first dose of the trial drug. 17. Subjects with symptoms of brain or leptomeningeal metastasis. 18. Subjects with a history of malignant tumors (non-study tumor) within 3 years before the first dose of the trial drug. 19. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
6 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Department of Bio-therapeutic, First Medical Center, Chinese PLA General Hospital
RECRUITINGBeijing, Beijing Municipality, 100853, China
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Department of Gynecologic Oncology, Shanxi Province Cancer Hospital
NOT_YET_RECRUITINGTaiyuan, Shanxi, 030013, China
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Department of Obstetrics and Gynecology, First Medical Center, Chinese PLA General Hospital
RECRUITINGBeijing, Beijing Municipality, 100853, China
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Department of Obstetrics and Gynecology, North China University of Science and Technology Affiliated Hospital
NOT_YET_RECRUITINGTangshan, Hebei, 063000, China
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Department of Obstetrics and Gynecology, Seventh Medical Center, Chinese PLA General Hospital
RECRUITINGBeijing, Beijing Municipality, 100007, China
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Peking University International Hospital
NOT_YET_RECRUITINGBeijing, Beijing Municipality, 102206, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Ovarian Cancer's spread: scientists probe abdominal fluid for clues
- New PET tracer aims to light up hidden cancer targets
- Mapping the DNA test that decides who gets PARP inhibitors
- Can a pill shrink Hard-to-Treat ovarian tumors?
- New antibody aims to preserve immune checkpoint while fighting cancer