Clinical trial · Interventional
A Study of Sintilimab Combined With Concurrent Chemoradiation Therapy in Locally Advanced Cervical Cancer
A Single-Arm, Single-Center Phase II Clinical Study of Sintilimab Combined With Concurrent Chemoradiation Therapy in The Treatment of Stage IIA2 To IVA (2018 FIGO) Locally Advanced Cervical Cancer
NCT05105672CI-TRIAL-00055693unknownPhase 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)
This is a single-arm, single-center phase II clinical study to explore the efficacy and safety of sintilimab combined with concurrent chemoradiation therapy as treatment in women with locally advanced cervical cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sintilimab | — | UNRESOLVED | — |
| Uterine Cervical Neoplasms | Cervical Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| brachytherapy | Radiation | — | UNRESOLVED |
| Cisplatin | Drug | Cisplatin | ALIAS |
| External Beam Radiotherapy (EBRT) | Radiation | — | UNRESOLVED |
| Sintilimab | Drug | Sintilimab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- chemoradiotherapy + Sintilimab
- description
- Participants will be given intravenous administration of sintilimab (200mg, q3w), cisplatin(75 mg/m², q3w) and Radiotherapy. After completing 2 cycles of concurrent chemoradiation, the Participants will continue to use 4 cycles of sintilimab (200mg, q3w) and cisplatin(75 mg/m², q3w) as maintenance therapy.
- interventionNames
- Drug: Sintilimab
- Drug: Cisplatin
- Radiation: External Beam Radiotherapy (EBRT)
- Radiation: brachytherapy
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 (3)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Has high-risk locally advanced cervical cancer (LACC): The International Federation of Gynecology and Obstetrics (FIGO) 2018 Stage IB3 or FIGO 2018 Stages IIA2-IVA. * Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Has radiographically evaluable disease, either measurable or non-measurable per RECIST 1.1 * Adequate hematological, renal and hepatic functions:Hemoglobin \> 9.0 g/dl; Neutrophils \> 2000 cells/μl; ANC \> 1.5 × 10\^9/L;Platelets \> 100 × 10\^9/L; Exclusion Criteria: * Has received prior therapy with an anti-programmed cell death receptor 1 (PD-1), anti-programmed cell death receptor ligand 1 (PD-L1), or anti-programmed cell death receptor ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX-40, CD137). * Has a known history of Human Immunodeficiency Virus (HIV) infection. * Prior malignancies (other than curable non-melanoma skin cancer) within 5 years
References
Publications (0)
Data not yet available
No reference posted for this study.