Clinical trial · Interventional
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
NCT06093438CI-TRIAL-00087037recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To explore the efficacy of incorporating neoadjuvant immunotherapy into neoadjuvant chemotherapy in locally advanced cervical cancer patients with high risk of recurrence.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Immunotherapy | — | UNRESOLVED | — |
| Induction Chemotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Toripalimab | Drug | Toripalimab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Induction immunotherapy and chemotherapy
- description
- Patients enrolled in this arm would receive neoadjuvant immunotherapy and chemotherapy before definitive chemoradiation
- interventionNames
- Drug: Toripalimab
Primary outcomes (2)
- measure
- Overall response rate
- timeFrame
- 1 year
- description
- The proportion of patients with at least one tumor scan of complete response (CR) or partial response (PR) using RECIST v1.1
- measure
- Volume changes of core radiation targets and irradiated normal tissues after induction treatment
- timeFrame
- 5-year
- description
- Volume change of PTV, PGTVnd, Bladder V45, V50, Dmax, Dmean, Rectum V45, V50, Dmax, Dmean, Bowel bag V45, V50
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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;
References
Publications (0)
Data not yet available
No reference posted for this study.