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New drug cocktail aims to shrink cervical tumors before surgery

NCT ID NCT07348861

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 25 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

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

18 to 65 years

Sex

Female participants only

Healthy volunteers

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

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.

cervical cancer Uterine Cervical Neoplasms

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.