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Induction Toripalimab and Chemotherapy in Locally Advanced Cervical Cancer

ConditionsCervical CancerInduction ChemotherapyImmunotherapy
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorTianjin Medical University Cancer Institute and Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Untreated locally advanced cervical cancer patients with clear pathological diagnosis

2019 FIGO stage IIIB-IVA. For patients with stage IIIC disease, the short diameter of their metastatic lymph nodes should ≥1.5cm

Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1

Life expectancy > 6 months

Disqualifiers

Concomitant other malignancies;

Patients with metastatic or recurrent disease;

Patients received any form of treatment before enrollment;

Severe concomitant chronic diseases (diabetes, hypertension, etc.) or acute infections;

Trial design

Design model

Single group

Treatments tested in this trial

  • Toripalimab

    Drug

    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).

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Induction immunotherapy and chemotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Overall response rate

The proportion of patients with at least one tumor scan of complete response (CR) or partial response (PR) using RECIST v1.1

Time frame
1 year
2

Volume changes of core radiation targets and irradiated normal tissues after induction treatment

Volume change of PTV, PGTVnd, Bladder V45, V50, Dmax, Dmean, Rectum V45, V50, Dmax, Dmean, Bowel bag V45, V50

Time frame
5-year

Secondary outcomes

1

Progression-free survival

Time from diagnosis of disease to disease progression or death due to any cause

Time frame
1-year, 2-year
2

Distant metastasis-free survival

Time from diagnosis to distant metastasis or death due to any cause

Time frame
1-year, 2-year
3

Incidence of treatment-related side effects

Incidence of treatment-related side effects (i.e., radiation-related proctitis, cystitis, ,vaginitis, etc.)

Time frame
5-year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tianjin Medical University Cancer Institute and Hospital

Lead sponsor

Source ClinicalTrials.gov
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