RecruitingPhase 1Phase 2NCT06093438

Induction Toripalimab and Chemotherapy in Locally Advanced Cervical Cancer

Induction Toripalimab and Chemotherapy in Locally Advanced Cervical Cancer Patients With High Risk of Recurrence: A Prospective, Single-Arm, Phase II Trial


Sponsor

Tianjin Medical University Cancer Institute and Hospital

Enrollment

20 participants

Start Date

Nov 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

To explore the efficacy of incorporating neoadjuvant immunotherapy into neoadjuvant chemotherapy in locally advanced cervical cancer patients with high risk of recurrence.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding the immunotherapy drug toripalimab to standard chemotherapy before chemoradiation improves outcomes for patients with locally advanced cervical cancer. The approach is called induction therapy — treatment given before the main course of treatment to try to shrink the cancer first. **You may be eligible if...** - You have been newly diagnosed with locally advanced cervical cancer (FIGO stage IIIB–IVA) that has not yet been treated - Pathology has confirmed the cancer type - You are in reasonably good health (ECOG 0-1) with a life expectancy of at least 6 months - Your blood, kidney, and liver function are adequate - You are female and willing to use effective contraception during the study **You may NOT be eligible if...** - You have another current cancer - You are pregnant or breastfeeding - You have active bleeding - You have serious autoimmune disease or other severe medical conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGToripalimab

Patients enrolled in this arm would receive three cycles of induction treatment before receiving definitive chemoradiotherapy. The specific regimen is: Paclitaxel(135mg/m2,ivd, d1)+cisplatin(75mg/m2,ivd,d1-3)+Toripalimab (240mg,ivd,d1)±bevacizumab(ivd, d1)/q21d. Patients would receive pelvic MRI to evaluate the regression status of tumor after three cycles of induction treatment. Patients with satisfying tumor regression would receive definitive chemoradiotherapy afterwards. During chemoradiotherapy, patients would receive weekly cisplatin (40mg/m2) and 240mg toripalimab every three weeks. After chemoradiotherapy, patients would receive another three cycles of consolidated treatment (regimen identical to induction treatment).


Locations(1)

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China

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NCT06093438


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