Toripalimab: 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).
Study 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
FEMALE
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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;
Primary outcome measure(s)
Overall response rate — 1 year The proportion of patients with at least one tumor scan of complete response (CR) or partial response (PR) using RECIST v1.1
Volume changes of core radiation targets and irradiated normal tissues after induction treatment — 5-year Volume change of PTV, PGTVnd, Bladder V45, V50, Dmax, Dmean, Rectum V45, V50, Dmax, Dmean, Bowel bag V45, V50
Trial sites (1)
Facility
City
Region
Status
Tianjin Medical University Cancer Institute & Hospital
Tianjin
Tianjin Municipality
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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