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New combo therapy shows promise for Tough-to-Treat cervical cancer

NCT ID NCT04341883

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested a combination of an immunotherapy drug (anti-PD-1) and a chemotherapy drug (albumin-bound paclitaxel) in 27 people whose cervical cancer had returned or worsened after standard treatment. The goal was to see if the combination could shrink tumors and help patients live longer. Participants received treatment every 3 weeks for up to 2 years. This is a phase 2 trial, meaning it's an early test of safety and effectiveness.

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

27 people

The number who actually took part.

Started

Jan 2020

Finished

Apr 2024

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 75 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. Voluntarily participate and have signed the informed consent form (ICF); 2. Patients histologically diagnosed with cervical cancer ; 3. Patients with advanced cervical cancer who have experienced progressive disease or relapse after receiving standard treatment (first-line chemotherapy must be included) or who are intolerant to first-line chemotherapy. 4. The radiological examination during screening confirms the presence of at least one measurable lesion evaluated according to the RECIST v1.1; 5. An Eastern Cooperative Oncology Group(ECOG) score of 0 or 1; 6. Life expectancy ≥ 3 months; 7. Adequate hepatic, renal, heart, and hematologic functions. Absolute Neutrophil Count(ANC) ≥ 1.5×109/L, Platelet (PLT) ≥ 70×109/L, Hemoglobin(HGB) ≥ 80 g/L, total bilirubin within 1.5×the upper limit of normal (ULN), and serum transaminase≤2.5×Upper Limit Of Normal(ULN), serum creatine ≤ 1.5 x Upper Limit Of Normal(ULN), creatinine clearance rate ≥50ml/min, International Normalized Ratio\<1.5 x Upper Limit Of Normal(ULN), Urinary protein≤(+)and Thyroid stimulating hormone≤ 1.5 x Upper Limit Of Normal(ULN). Exclusion Criteria: 1. Pathology confirmed with sarcoma components (including malignant mixed mullerian tumors, endometrial leiomyosarcoma, and endometrial stromal sarcoma); 2. Patients who have previously received albumin-bound paclitaxel or exposures to any anti-PD-1 antibody drugs; 3. Exposures to any anti-tumor drugs within 4 weeks; 4. Current or prior use of any immunosuppressive medication or systemic hormone therapy(which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid Prednisone\>10mg/d)within 14 days before the first dose of anti-PD-1 antibody; 5. Any primary malignancy within 5 years (except for fully treated in situ malignant such as breast cancer, bladder cancer, cervical carcinoma in situ, cutaneous basal cell carcinoma or squamous cell carcinoma); 6. History of psychiatric drugs abuse and not be abstinent, or dysphrenia; 7. Central nervous system diseases, including uncontrollable epilepsy and symptomatic brain metastases; 8. Severe cardiovascular disease: unstable angina pectoris, myocardial infarction, grade III-IV cardiac insufficiency (NYHA standard), and peripheral vascular disease above 2 degrees within 6 months prior to enrollment; 9. Severe arrhythmia requiring drug control, QT interval \>470ms; 10. Active infections such as HIV/AIDS or other serious infectious diseases; 11. Any active autoimmune disease or history of autoimmune disease (including but not limit to autoimmune hepatitis, interstitial pneumonia, hepatitis, enteritis, nephritis, hyperthyroidism, pituitary inflammation, vasculitis, uveitis) . Patients need receiving systemic hormonal therapy and/or immunosuppressive therapy (eg asthma requiring bronchodilators); 12. Receipt of live attenuated vaccination within 30 days prior to study entry; 13. Other conditions regimented at investigators' discretion.

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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

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060, China

More trials for these conditions

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