Clinical trial · Interventional
A Study of Chemoradiotherapy With SHR-1316 For Treatment of Locally Advanced Cervical Cancer
NCT06237257CI-TRIAL-00084016unknownPhase 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)
The Primary purpose of this study is to evaluate the safety of SHR-1316 plus concurrent chemoradiotherapy in participants with locally advanced cervical cancer. The second purpose of this study is to evaluate the efficacy and PK traits; The exploratory study is to explore the biomarker 、immunogenicity and so on .
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 |
|---|---|---|---|
| Locally Advanced Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin Injection/Carboplatin Injection | Drug | — | UNRESOLVED |
| External Beam Radiotherapy (EBRT)/Brachytherapy | Radiation | — | UNRESOLVED |
| Paclitaxel Injection | Drug | Paclitaxel | ALIAS |
| SHR-1316 | Biological | Adebrelimab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SHR-1316 plus concurrent chemoradiotherapy
- interventionNames
- Biological: SHR-1316
- Drug: Cisplatin Injection/Carboplatin Injection
- Radiation: External Beam Radiotherapy (EBRT)/Brachytherapy
- Drug: Paclitaxel Injection
Primary outcomes (1)
- measure
- Type, incidence and grade of drug-related adverse events of grade 3 and above
- timeFrame
- Up to approximately 24 months
Secondary outcomes (17)
- measure
- Adverse events (AEs) include incidence, grade (judged according to NCI-CTCAE V5.0 standards), duration and correlation with study drugs
- timeFrame
- Up to approximately 30 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Able and willing to provide a written informed consent 2. Has histologically-confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix； 3. Has locally advanced cervical cancer； 4. At least one measurable lesion ( RECIST version 1.1)； 5. Investigator assess it is suitable for concurrent chemoradiotherapy; 6. Has provided a tissue sample from tumor lesion; 7. Cooperative Oncology Group (ECOG) performance status of 0 or 1; 8. BMI≥18.5kg/m2； 9. Female participants of childbearing potential must agree to use highly effective contraception during the treatment period and for at least 7 months after the last dose of drug，Female participants' HCG must be negative within 3 days prior to enrollment and must be non-lactating. Exclusion Criteria: 1. Histopathologically confirmed small cell carcinoma (neuroendocrine) or mucinous adenocarcinoma of the cervix； 2. The presence of distant metastatic disease was confirmed by pathology or imaging; 3. has previously undergone hysterectomy (including subtotal hysterectomy) or plan to undergo hysterectomy for cervical cancer, or plan to adopt fertility preservation therapy; 4. In the investigator's judgment, there is a disease (such as severe diabetes, neurological or psychiatric illness, etc.) or any other condition that seriously endangers the subject's safety, confuses the study results, or interferes with the subject's ability to complete the study.
References
Publications (0)
Data not yet available
No reference posted for this study.