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Cervical cancer trial pulled before it started

NCT ID NCT06866951

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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study was designed to compare chemo-immunotherapy (chemotherapy plus a PD-1 inhibitor) against standard chemoradiotherapy for cervical cancer patients whose cancer had spread to lymph nodes after surgery. The goal was to see which approach better prevented cancer from returning or spreading. However, the trial was withdrawn before enrolling any participants, so no results are available.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Chemo-immunotherapy (paclitaxel, cisplatin/carboplatin, and PD-1 inhibitor)

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Started

Mar 2025

Expected to finish

Dec 2030

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 70 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. Patients with cervical squamous cell carcinoma, adenocarcinoma (usual type), or adenosquamous carcinoma who have been pathologically confirmed to have positive retroperitoneal lymph nodes after radical surgery for cervical cancer, i.e., patients with stage IIIC1p and IIIC2p cervical cancer (FIGO 2018); 2. Positive expression of PD-L1 in pathological examination, i.e., Combined Positive Score (CPS) ≥1; 3. Patients aged ≥18 years and ≤70 years; 4. ECOG performance status score ≤1; 5. Laboratory tests: White blood cell count (WBC) ≥3.5×10\^9/L, neutrophil count (NEU) ≥1.5×10\^9/L, platelet count (PLT) ≥100×10\^9/L, serum total bilirubin ≤1.5 times the upper limit of normal, serum alanine aminotransferase (ALT) and serum aspartate aminotransferase (AST) ≤1.5 times the upper limit of normal, serum blood urea nitrogen (BUN) ≤1.5 times the upper limit of regular or creatinine clearance rate ≥50 mL/min (creatinine clearance rate can be calculated using the Cockcroft-Gault formula, the Chronic Kidney Disease Epidemiology Collaboration formula, or the Modification of Diet in Renal Disease formula); 6. Good compliance of the subjects, who can follow the protocol for efficacy follow-up and adverse events/reactions; 7. Subjects voluntarily sign the informed consent form, including adherence to the requirements and restrictions listed in the informed consent form and this protocol. Exclusion Criteria: 1. Postoperative pathology indicates positive parametrial involvement or positive surgical margins; 2. Incomplete radical surgery; 3. Postoperative imaging confirms the presence of residual target lesions; 4. Any active autoimmune disease or a history of autoimmune disease requiring systemic treatment, including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, thyroid dysfunction, and asthma requiring intervention with bronchodilators; 5. Previous treatment with immune checkpoint inhibitors, including but not limited to other anti-PD-1 and anti-PD-L1 antibodies; known allergy to any component of the study medication or other monoclonal antibodies; 6. History of human immunodeficiency virus (HIV) infection, active hepatitis B (HBV-DNA ≥ 2000 IU/mL or 10⁴ copies/mL), or hepatitis C (positive hepatitis C antibody and HCV-RNA above the lower limit of detection of the assay method); 7. Receipt of immunosuppressive drugs or systemic corticosteroid therapy for immunosuppressive purposes within 2 weeks before the study drug administration (dose \>10 mg/day of prednisone or equivalent); 8. Diagnosis of another primary malignancy within 5 years before the first use of the investigational drug. 9. Use any other investigational drug/treatment from another clinical trial within 4 weeks before randomization or concurrent participation in another interventional clinical trial. Participation in observational, non-interventional clinical trials is permitted; 10. Pregnant or breastfeeding female patients; 11. Uncontrolled concomitant diseases, including but not limited to: * Cardiovascular diseases: New York Heart Association (NYHA) functional class II or higher, severe/unstable angina, myocardial infarction within ≤6 months before study drug administration, or significant arrhythmias requiring medication or intervention; * Uncontrolled hypertension; * Cerebrovascular events or central nervous system disorders within ≤6 months before study drug administration, or patients with abnormal mental status; * Hematologic disorders: Coagulopathy (INR \> 2.0, PT \> 16 seconds), bleeding tendency, or ongoing thrombolytic or anticoagulant therapy; * Hepatic or renal developmental abnormalities or history of surgery; * Any active infection requiring systemic antimicrobial therapy within 14 days before the first dose of the study drug; 12. Receipt of any live or attenuated vaccines within 4 weeks before the first dose of the study drug. Administration of seasonal inactivated influenza vaccine is permitted; 13. Patients who have previously undergone allogeneic bone marrow transplant or solid organ transplantation; 14. History of drug and/or alcohol abuse; 15. Patients deemed by the investigator unlikely to comply with study procedures, restrictions, and requirements are not eligible for participation in this study.

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Conditions

The condition(s) this trial relates to.

cervical cancer cervical carcinoma Uterine Cervical Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Womens' Hosptial, School of Medicine, Zhejiang University

    Hangzhou, Zhejiang, 310000, China

More trials for these conditions

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