New combo therapy shows promise for Tough-to-Treat cervical cancer
NCT ID NCT04341883
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.
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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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27 people
The number who actually took part.
- Started
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Jan 2020
- Finished
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Apr 2024
- 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 75 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. 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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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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.
- Can an immunotherapy-angiogenesis combo outshine standard chemo for advanced cervical cancer?
- Blood test may spot returning cervical cancer before symptoms appear
- New registry aims to learn from Real-World retreatment of gynecologic cancers
- Immunotherapy combo shows promise for advanced cervical cancer
- New combo therapy offers hope for advanced cervical cancer patients
- New drug duo targets advanced gynecologic cancers in early trial