Promising drug cocktail targets Hard-to-Treat cervical cancer
NCT ID NCT07363330
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This phase II trial tests a combination of two drugs—Utidelone and Toripalimab—in people with recurrent or metastatic cervical cancer that has stopped responding to standard treatments. All 32 participants will receive the same treatment, and doctors will monitor tumor shrinkage and side effects. The goal is to see if this combination can shrink tumors and improve outcomes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Utidelone and Toripalimab
- What this could lead to
- If successful, this combination could offer a new treatment option for patients with recurrent or metastatic cervical cancer who have run out of standard therapies.
- What could go wrong
- This is a small, early-phase study with only 32 participants and no comparison group, so results may not apply broadly. Side effects from the drug combination are possible and will be closely monitored.
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 32 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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Dec 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 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. Informed Consent: Patients must voluntarily sign an informed consent form prior to any study-related procedures. 2. Age: Aged ≥18 years and ≤75 years. 3. Diagnosis: Histologically or cytologically confirmed recurrent or metastatic cervical carcinoma. 4. Performance Status: With an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 5. Measurable Disease: With at least one measurable lesion as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. 6. Prior Therapy: * Patients must have received at least one line of standard systemic chemotherapy for recurrent/metastatic disease, OR * Patients with rapid disease progression (occurring within 6 months) during or after prior neoadjuvant or concurrent chemoradiotherapy. 7. Treatment-Related Toxicity: Recovery from all toxicities related to prior anti-cancer therapies to ≤ Grade 1 (according to CTCAE v5.0). Patients with alopecia of any grade are eligible. 8. Adequate Hematological Function (within 1 week prior to enrollment, per local laboratory reference ranges): * White blood cell count (WBC) ≥ 2.5 × 10⁹/L. * Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L. * Platelet count (PLT) ≥ 100 × 10⁹/L. * Hemoglobin (Hb) ≥ 9.0 g/dL (transfusion or erythropoietin use is permitted to meet this criterion). 9. Adequate Liver and Kidney Functions (within 1 week prior to enrollment, per local laboratory reference ranges): * Total bilirubin (TBIL) ≤ 1.5 × the upper limit of normal (ULN). * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (≤ 5 × ULN for patients with liver metastases). * Calculated creatinine clearance (Ccr) ≥ 60 mL/min. 10. Contraception: Patients of childbearing potential must agree to use highly effective contraception during the study and for at least 90 days after the last dose of study treatment. A negative serum or urine pregnancy test is required for female patients of childbearing potential within 7 days prior to enrollment. 11. Life Expectancy: Anticipated life expectancy of at least 12 weeks. 12. Compliance: Patients must be able and willing to comply with the study protocol for treatment and follow-up. Exclusion Criteria: 1. Concurrent Malignancy: History of other active malignancies within the past 5 years, except for adequately treated basal cell carcinoma of the skin. 2. Recent Anti-cancer Therapy: Any anti-cancer therapy (including chemotherapy, radical radiotherapy, hormonal therapy, biological therapy, or anti-cancer Chinese herbal medicine) within 4 weeks prior to the initiation of study treatment. 3. Recent Major Surgery/Trauma: Major surgical procedure (excluding diagnostic biopsy) or significant traumatic injury within 4 weeks prior to the first dose of study drug, or anticipation of the need for major surgery during the study period. 4. Prior Neurotoxicity: History of ≥ Grade 3 neurological adverse reactions attributed to prior anti-microtubule therapy. 5. Symptomatic CNS Metastases: Patients with symptomatic central nervous system (CNS) metastases. 6. Pregnancy/Lactation: Women who are pregnant or breastfeeding. 7. Hypersensitivity: Known or suspected hypersensitivity to any component of the study drugs or their excipients. 8. Severe Comorbidities: Any uncontrolled or severe concurrent medical condition that, in the investigator's judgment, would preclude participation, including but not limited to: * Severe cardiovascular or cerebrovascular disease. * Uncontrolled diabetes mellitus or hypertension. * Active severe infection. * Active peptic ulcer disease. * Uncontrolled psychiatric illness/disorder. 9. General Exclusion: Any other condition or circumstance that, in the opinion of the investigator, would compromise the patient's safety or compliance, or make the patient unsuitable for study participation. 10. Contraindication to Steroids: Conditions for which corticosteroid use is contraindicated.
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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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Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430000, China
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