Induction Toripalimab and Chemotherapy in Locally Advanced Cervical Cancer

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 Criteria:

1. Untreated locally advanced cervical cancer patients with clear pathological diagnosis
2. 2019 FIGO stage IIIB-IVA. For patients with stage IIIC disease, the short diameter of their metastatic lymph nodes should ≥1.5cm
3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
4. Life expectancy \> 6 months
5. Able to tolerate concurrent chemoradiotherapy assessed by researches
6. No obvious active bleeding;
7. Adequate hematological, renal and hepatic functions:
8. No concomitant malignancies
9. Female subjects of childbearing potential should have a negative pregnancy test and must take effective and reliable contraceptive measures during the clinical trial period;
10. Voluntarily-signed informed consent.

Exclusion Criteria:

1. Concomitant other malignancies;
2. Patients with metastatic or recurrent disease;
3. Patients received any form of treatment before enrollment;
4. Severe concomitant chronic diseases (diabetes, hypertension, etc.) or acute infections;
5. Impaired hematological, renal or hepatic functions:

   1. Hemoglobin \< 9.0 g/dl
   2. Neutrophils \< 2000 cells/μl; Leukocytes \< 4 × 109/L
   3. Platelets \> 100 × 109/L
   4. Serum ALT/AST \> 2.5×UNL
   5. 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)
6. Patients with obvious arrhythmia, myocardial ischemia, severe atrioventricular block, cardiac insufficiency or severe heart valve disease;
7. Patients with uncontrolled mental diseases;
8. Pregnant or lactating woman;
9. Participating in other clinical trials;
10. Anyone considered not suitable for enrollment by principal investigator;

Conditions4

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