ctDNA-guided First-line Immuno-de-escalation Therapy for IVB-stage and Recurrent Cervical Cancer

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorObstetrics & Gynecology Hospital of Fudan University

About this trial

This study aims to evaluate the clinical feasibility of first-line immunochemotherapy for stage IVB and recurrent cervical cancer guided by circulating tumor DNA (ctDNA), in order to explore the optimal treatment duration or criteria for discontinuation of first-line immunotherapy in patients with stage IVB cervical cancer or recurrent cervical cancer. To ensure the quality of the study, before the study begins, the research applicant and participants jointly discuss and formulate the research plan. Necessary steps should be taken during the design and implementation stages of the study to ensure that the collected data is accurate, consistent, complete, and credible.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Clinically diagnosed as stage IVB primary treatment and recurrent cervical cancer patients (this relapse has not been systematically treated); Histologically or cytologically confirmed recurrent or metastatic cervical cancer, pathological types are squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma; Age ≥18 years old and ≤75 years old, female; Signed written informed consent form, and able to comply with the visitation and related procedures specified in the protocol; Has not received systematic treatment for primary stage IVB or this relapse; Has at least one measurable lesion (RECIST 1.1 version); ECOG performance status 0-1; Estimated survival time ≥3 months; Menopausal trial participants must agree to use effective contraceptive measures during the trial; pregnant women must have a negative serum or urine pregnancy test.

Disqualifiers

Patients with pathological types other than squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma (e.g., small cell carcinoma, clear cell carcinoma, etc.).

Trial design

Design model

Single group

Treatments tested in this trial

  • cadonilimab combined with cisplatin-based chemotherapy ± bevacizumab

    Drug

    Patients with persistent, recurrent, or advanced metastatic cervical cancer who have not received systemic treatment are treated with cadonilimab combined with cisplatin-based chemotherapy ± bevacizumab (treatment dosage: cadonilimab 10 mg/kg, paclitaxel 175 mg/m\^2, cisplatin 50 mg/m\^2, cisplatin AUC 4-5, bevacizumab 7.5-15 mg/kg), once every 3 weeks, for a total of 6 cycles (if the patient continues to benefit, chemotherapy is allowed beyond 6 cycles), followed by maintenance treatment with cadonilab ± bevacizumab.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Plasma ctDNA negative groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The accuracy of plasma ctDNA as a guide for adaptive immune chemotherapy in patients with stage IVB and recurrent cervical cancer.

Time frame
The time frame was from subject enrollment until post-treatment follow-up for two years

Secondary outcomes

Other outcomes

Sponsors and contacts

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