A Phase II Study of Utidelone With Toripalimab in Advanced Cervical Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorZhongnan Hospital
About this trial
This is a Phase II clinical trial to evaluate the safety and efficacy of Utidelone, a genetically engineered epothilone derivative, combined with Toripalimab, a PD-1 inhibitor, in patients with recurrent or metastatic cervical cancer who have progressed after standard treatments. The study will also assess the safety profile of this combination therapy. The primary objectives of this study include: (1) to determine the objective response rate (ORR), meaning whether the treatment can reduce the size of tumors or make them disappear, according to the RECIST 1.1 criteria; (2) to evaluate the safety of the treatment and document the side effects experienced by participants. This study is for individuals who: (1) are between 18 and 75 years old; (2) have a confirmed diagnosis of recurrent or metastatic cervical cancer; (3) have previously received at least one standard chemotherapy regimen that is no longer controlling the cancer; (4) are in generally good health, as determined by the study investigators. In this single-arm study, all participants will receive the same treatment: Utidelone will be administered by intravenous (IV) infusion over 1.5 hours, once a day for 5 consecutive days, in each 21-day treatment cycle; Toripalimab will be administered by IV infusion over 1.5 hours, once on Day 6 of each 21-day cycle. Participants may continue receiving the study drugs as long as they are benefiting from the treatment and side effects are manageable. Doctors will assess tumor size using imaging scans (like CT or MRI) every 6 weeks to monitor how the cancer responds to treatment. The study will take place at Zhongnan Hospital of Wuhan University and plans to include approximately 32 participants.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Informed Consent: Patients must voluntarily sign an informed consent form prior to any study-related procedures.
Age: Aged ≥18 years and ≤75 years.
Diagnosis: Histologically or cytologically confirmed recurrent or metastatic cervical carcinoma.
Performance Status: With an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
Disqualifiers
Concurrent Malignancy: History of other active malignancies within the past 5 years, except for adequately treated basal cell carcinoma of the skin.
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.
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.
Prior Neurotoxicity: History of ≥ Grade 3 neurological adverse reactions attributed to prior anti-microtubule therapy.
Trial design
Design model
Single group
Treatments tested in this trial
Utidelone plus Toripalimab
Drug1. Drug: Utidelone (1)Dosage: 30 mg/m² (2)Route of Administration: Intravenous drip (IV infusion) (3)Schedule: Administered once daily on Days 1-5 of each cycle. (4)Cycle Duration: 21 days (q3w). 2. Drug: Toripalimab (1)Dosage: 240 mg (2)Route of Administration: Intravenous drip (IV infusion) (3)Schedule: Administered on Day 6 of each cycle. (4)Cycle Duration: 21 days (q3w).
Treatment groups
32 Participants
are divided into 1 treatment groupGroup A: Utidelone plus ToripalimabExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Objective response rate (ORR)
Time frame
Tumor assessments are performed at baseline and every 6 weeks (± 3 days) until progression or start of new therapy. ORR is analyzed after all patients have completed at least 18 weeks of follow-up or experienced a study endpoint event.Secondary outcomes
1
Progression-Free Survival (PFS)
Time frame
From the date of enrollment until first documented disease progression (per RECIST 1.1) or death from any cause, whichever occurs first, assessed up to approximately 24 months.2
Time to Response (TTR)
Time frame
From the date of enrollment to the first documented objective response (Complete or Partial Response per RECIST 1.1), assessed up to approximately 24 months.3
Duration of Response (DoR)
Time frame
From the date of first documented objective response (CR or PR) until documented disease progression or death due to underlying cervical cancer, assessed up to approximately 36 months.4
Overall Survival (OS)
Time frame
From the date of enrollment until death from any cause, assessed up to approximately 36 months.Sponsors and contacts
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Source ClinicalTrials.gov
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