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
Tianjin Medical University Cancer Institute and Hospital
20 participants
Nov 1, 2023
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
Inclusion Criteria10
- Untreated locally advanced cervical cancer patients with clear pathological diagnosis
- 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
- Able to tolerate concurrent chemoradiotherapy assessed by researches
- No obvious active bleeding;
- Adequate hematological, renal and hepatic functions:
- No concomitant malignancies
- Female subjects of childbearing potential should have a negative pregnancy test and must take effective and reliable contraceptive measures during the clinical trial period;
- Voluntarily-signed informed consent.
Exclusion Criteria16
- 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;
- Impaired hematological, renal or hepatic functions:
- Hemoglobin \< 9.0 g/dl
- Neutrophils \< 2000 cells/μl; Leukocytes \< 4 × 109/L
- Platelets \> 100 × 109/L
- Serum ALT/AST \> 2.5×UNL
- Serum Total bilirubin \> 1.5× UNL
- g. Serum urea nitrogen (BUN) \> 1.5 × upper normal limit (UNL) h. Serum creatinine (Cr) \> 1.5 × upper normal limit (UNL)
- Patients with obvious arrhythmia, myocardial ischemia, severe atrioventricular block, cardiac insufficiency or severe heart valve disease;
- Patients with uncontrolled mental diseases;
- Pregnant or lactating woman;
- Participating in other clinical trials;
- Anyone considered not suitable for enrollment by principal investigator;
Interventions
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)
View Full Details on ClinicalTrials.gov
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NCT06093438