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

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

For locally advanced cervical cancer patients undergoing definitive chemoradiotherapy, distant metastasis has become a major concern. In this study, investigators selected a subgroup of patients with theoretically higher risk of distant metastasis and intensified their systematic treatment by incorporating PD-L1 inhibitors into neoadjuvant chemotherapy, in order to reduce their risk of distant metastasis and achieve good disease-free survival.

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;