Clinical trial · Interventional
Toripalimab Combined With Concurrent Chemoradiotherapy in Cervical Cancer
Toripalimab Combined With Concurrent Platinum-based Chemoradiotherapy in Patients With Locally Advanced Cervical Cancer: An Open-Label, Single-Arm, Phase II Trial
NCT05084677CI-TRIAL-00073073unknownPhase 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 and tolerance of adding toripalimab simultaneously and subsequently to concurrent platinum-based chemoradiotherapy in patients with locally advanced cervical cancer.
Conditions
Conditions (1)
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 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Toripalimab Combined With Concurrent Platinum-based Chemoradiotherapy | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PD-1 arm
- description
- PD-1 concurrent with and subsequent after concurrent chemoradiotherapy
- interventionNames
- Combination Product: Toripalimab Combined With Concurrent Platinum-based Chemoradiotherapy
Primary outcomes (1)
- 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
Secondary outcomes (2)
- measure
- Progression free survival
- timeFrame
- 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Age between 18 and 75; * Untreated patients with pathologically proven locally advanced cervical cancer; * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 * Adequate hematological, renal and hepatic functions: 1. Hemoglobin \> 8.0 g/dl 2. Neutrophils \> 2000 cells/μl; Leukocytes \> 4 × 109/L 3. Platelets \> 100 × 109/L g. Serum urea nitrogen (BUN) ≤ 1.5 × upper normal limit (UNL) h. Serum creatinine (Cr) ≤ 1.5 × upper normal limit (UNL) d. Serum ALT/AST ≤ 2.5× UNL e. Serum Total bilirubin ≤ 1.5× UNL * Life expectancy \> 6 months * Eligible for concurrent chemoradiotherapy assessed by principle investigator; * No obvious active bleeding; * Written informed consent must be available before study registration Exclusion Criteria: * Recurrent or distant metastatic disease; * Prior malignancies (other than curable non-melanoma skin cancer) within 5 years; * Active autoimmune diseases requiring systemic treatment or other diseases requiring long-term use of substantial amount of hormones or other immunosuppressants; * Patients who need to receive systemic corticosteroids (dose equivalent to or higher than prednisone 10mg qd) or other immunosuppressants within 14 days before enrollment or during the study; * Vaccination of live attenuated vaccine 30 days before enrollment, or planned vaccination of live attenuated vaccine during the study; * Previous organ transplantation or HIV patients; * Allergic to macromolecular proteins /monoclonal antibodies, or to any test drug component; * Active acute or chronic viral hepatitis B or C. Hepatitis B virus (HBV) DNA\> 2000IU/ml or 104 copies/ml; hepatitis C virus (HCV) RNA\> 103 copies/ml.
References
Publications (2)
- DERIVEDChen J, Shi J, Cao Y, Li C, Li J, Yuan Z. A new treatment approach of toripalimab in combination with concurrent platinum-based chemoradiotherapy for locally advanced cervical cancer: A phase II clinical trial. Int J Cancer. 2025 Feb 15;156(4):817-825. doi: 10.1002/ijc.35206. Epub 2024 Sep 28. PMID 39340335
- DERIVEDChen J, Li C, Cao Y, Zhu L, Zhang B, You J, Hou H, Wang J, Yuan Z. Toripalimab combined with concurrent platinum-based Chemoradiotherapy in patients with locally advanced cervical Cancer: an open-label, single-arm, phase II trial. BMC Cancer. 2022 Jul 19;22(1):793. doi: 10.1186/s12885-022-09866-w. PMID 35854236