New drug cocktail aims to shrink cervical tumors before surgery
NCT ID NCT07348861
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a combination of three drugs (sacituzumab tirumotecan, iparomlimab, and tuvonralimab) given before surgery to people with locally advanced cervical cancer. The goal is to see if the treatment can completely eliminate the tumor before the operation. About 25 participants will take part in this early-phase trial.
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 25 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Feb 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2028
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 65 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. Voluntary participation in the clinical study; complete understanding, knowledge of this study and signing informed consent; willingness to follow and ability to complete all trial procedures; 2. Histopathology confirmed cervical scaly carcinoma, adenocarcinoma, and adenocarcinoma. If there are small cell carcinomas, neuroendocrine carcinomas, and sarcoma components, they cannot be grouped ; 3. Locally advanced cervical cancer, according to FIGO2018 stage, conforming to stage IIB/IIIc1r with IB3, IIA2, and tumor diameter ≥ 4 cm; 4. Has not previously received any other anti-tumor treatment ; 5. Age 18-65 years ; 6. The physical fitness score of the Eastern U.S. Oncology Cooperation Group (ECOG) was 0 to 1 score ; 7. Life expectancy exceeds 3 months ; 8. Organ function and hematopoietic function must meet the following requirements: Hemoglobin (HGB) ≥80g/L; Leukocyte count (WBC) ≥ 3×109/L; absolute neutrophil count (ANC) ≥ 1.5 × 109/L ; Platelet count (PLT) ≥80×109/L; Total cholugin (TBIL) ≤ 1.5 × normal value upper limit (ULN) ; aspartate transaminase AST) and aspartate transaminase (ALT) ≤ 2.5 × ULN ; If hepatic dysfunction is caused by tumor hepatic metastasis, AST and ALT ≤ 5 × ULN ; Serum creatinine (Cr) ≤ 1.5 × ULN; or creatinine clearance rate (CrCl) ≥ 50 mL/min; International standardized ratio (INR) or plasma coagulase prime time (PT) ≤ 1.5 × ULN. 9. Female subjects in childbearing age must agree to effective contraception measures within 5 months after signing a informed consent form, during the study period, and after the last administration of the drug ; 10. Subjects must agree to provide sufficient tumor tissue samples for PD-L1, TROP2 expression detection. This includes archived tumor samples (paraffin blocks or untainted sections in quantity that meet the testing requirements specified by this institute); without archived tumor tissue samples, subjects agree to undergo tumor lesion rebiometry. Exclusion Criteria: 1. Research treatments that have begun to receive other anti-tumor treatments (including chemotherapy, molecular targeting therapy, radiotherapy, immunotherapy, monoclonal antibody therapy), or that have participated in other non-marketing drug clinical studies ; 2. Subjects known to have previously been allergic to macromolecular protein preparations / monoclonal antibodies, or known to be allergic to the composition of any experimental drug ; 3. pregnant or breastfeeding women ; 4. Those with active autoimmune diseases and who have received systematic treatment (such as corticosteroids or immunosuppressive drugs) within the past 2 years (such as, but not limited to: meningitis, enteritis, hepatitis, pituitary, vascular, nephritis, hyperthyroidism, hypothyroidism \[inclusive for non-clinical symptomatic hypothyroidism or hypothyroidism due to chemotherapy\]; those with vitiligo or who had complete remission of asthma in childhood and need no intervention in adulthood;) 5. Whole-body corticosteroid (dosage equivalent to or greater than 10 mg/day strong pine) or other immunosuppressive drug therapists were required within 14 days prior to group admission or during the study period ; 6. Individuals who received live vaccination within 4 weeks of treatment initiation ; 7. Those who have received anti-tumor vaccines, or those who have received anti-tumor therapies with systemic immunostimulatory effects ; 8. With serious medical conditions, such as severe infections, uncontrollable diabetes, cardiovascular disease (classified by the New York Heart Association as Class III or IV heart failure, cardiovascular obstruction above Class II, myocardial infarction within the past 6 months, unstable arrhythmia or unstable angina, cerebral infarction within 3 months, etc.) or pulmonary disease (history of interstitial pneumonia, obstructive pulmonary disease, and symptomatic Bronchospasm); 9. Hepatitis C virus deoxyribonucleic acid (HBV DNA) \> 103 copies/ml positive for hepatitis C surface antigen (HBsAg) and/or hepatitis C core antibody (HBcAb), or hepatitis C virus antibody positive; syphilis positive; 10. Has a history of human immunodeficiency virus infection, or has other acquired, congenital immunodeficiency diseases ; 11. Those with an active tuberculosis infection history within 1 year prior to group admission ; 12. Patients with other malignancies within 5 years of group entry, except for any previously cured type of in situ carcinoma and cured skin basal-cell carcinoma or skin scaly carcinoma ; 13. Previously received exogenous hematopoietic stem cell or solid organ transplantation ; 14. Those with a history of gastrointestinal perforation or who underwent excessive surgical surgery (excluding baseline tumor biopsies) or who suffered severe trauma, active ulcers, intestinal perforation, intestinal obstruction, and unhealed fractures within the first 4 weeks of study treatment ; 15. Has a history of alcoholism, drug use or drug abuse within the past 1 year ; 16. Having a clear history of neurological or mental disorders, such as epilepsy, dementia, and dependence disorder; 17. Other severe, acute, or chronic diseases or laboratory abnormalities that may increase the risk of participation in studies and study drug use, or may interfere with the interpretation of study results ; 18. People with previous eye surface disorders, e.g.: dry eye disease, corneal inflammation, etc. conditions ; 19. The presence of a relative or absolute taboo condition for abdominal cervical cancer surgery ; 20. Researchers consider participants unsuitable for this study due to other reasons.
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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
Guangzhou, Guangdong, China
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Other studies related to the condition(s) this trial covers.
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