Dual immunotherapy plus chemo may shrink cervical tumors before surgery
NCT ID NCT07646301
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial is testing a combination of two immunotherapy drugs (iparomlimab and tuvonralimab) plus standard chemotherapy before surgery in 103 women with locally advanced cervical cancer. The goal is to see if this approach can shrink tumors enough to allow less extensive surgery, potentially preserving more of the cervix. Participants will receive up to 4 cycles of the drug combo, then surgery, and possibly maintenance therapy if they respond well.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Iparomlimab and tuvonralimab (a dual immunotherapy drug) plus paclitaxel and platinum chemotherapy
- What this could lead to
- If successful, this approach could shrink tumors enough to allow less invasive surgery, preserving more of the cervix and potentially improving quality of life.
- What could go wrong
- This is an early phase 2 trial with only 103 participants, so results may not apply to everyone. Immunotherapy can cause serious side effects like inflammation of organs, and not all patients will respond.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 103 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2029
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 70 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. Age 18 to 70 years. 2. Histologically or cytologically confirmed cervical cancer, FIGO stage IB3 or IIA2. 3. Imaging findings showing pelvic lymph node short-axis diameter \< 1.5 cm and para-aortic lymph node short-axis diameter \< 1.5 cm. 4. Pathological diagnosis of cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma. 5. No prior anti-tumor therapy. 6. Eastern Cooperative Oncology Group (ECOG) performance status 0-1. Exclusion Criteria: 1. Presence of other concurrent malignancies. 2. Pregnant or peripartum women. 3. History of myocardial infarction or stroke, unstable angina, decompensated heart failure, or deep vein thrombosis. 4. Presence of NCI-CTCAE version 5.0 grade ≥2 arrhythmia, any grade of atrial fibrillation, or clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention. 5. Active unresolved hepatitis, defined as progressive decrease in appetite, general weakness, nausea, acid reflux, aversion to oily foods, abdominal distension, or abnormal liver function with jaundice (e.g., scleral or urinary jaundice); for hepatitis B, HBV DNA \> 1000 IU/mL. 6. Hepatic insufficiency (aspartate aminotransferase/alanine aminotransferase \> 2.5 × upper limit of normal). 7. Renal insufficiency (serum creatinine \> 2 × upper limit of normal). 8. History of chronic pulmonary disease with restrictive respiratory dysfunction. 9. History of major organ transplantation or autoimmune disease. 10. History of severe mental illness or cerebral dysfunction. 11. History of substance abuse or drug addiction. 12. Use of immunosuppressive agents or systemic corticosteroids for immunosuppressive purposes (dose \> 10 mg prednisone or equivalent) within 2 weeks prior to enrollment, with ongoing use. 13. Coagulation abnormality (INR \> 2.0, PT \> 16 seconds), bleeding tendency, or ongoing thrombolytic or anticoagulant therapy (prophylactic low-dose aspirin and low-molecular-weight heparin are permitted). 14. Congenital or acquired immunodeficiency (e.g., HIV infection). 15. Receipt of inactivated vaccine within 30 days prior to the first dose of study treatment. 16. Inability or unwillingness to provide written informed consent or comply with study requirements.
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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
1 site. 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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Sun Yat-sen University Cancer Center
RECRUITINGGuangzhou, Guangdong, 510060, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Double-Target immunotherapy added to standard care for aggressive cervical cancer
- Robotic surgery vs standard approaches: does the platform change cancer outcomes?
- Immunotherapy added to chemo aims to boost cervical cancer remission
- A new strategy to prevent cervical cancer: community follow-up for HPV shots
- Can adding immunotherapy to standard cancer care be safe for indian patients?
- Why does cervical cancer persist despite prevention tools? a study seeks answers