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Trial Title:
A Study of Chemoradiotherapy With SHR-1316 For Treatment of Locally Advanced Cervical Cancer
NCT ID:
NCT06237257
Condition:
Locally Advanced Cervical Cancer
Conditions: Official terms:
Uterine Cervical Neoplasms
Carboplatin
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
SHR-1316
Description:
SHR-1316（Adebrelimab Injection）
Arm group label:
SHR-1316 plus concurrent chemoradiotherapy
Intervention type:
Drug
Intervention name:
Cisplatin Injection/Carboplatin Injection
Description:
Cisplatin Injection/Carboplatin Injection
Arm group label:
SHR-1316 plus concurrent chemoradiotherapy
Intervention type:
Radiation
Intervention name:
External Beam Radiotherapy (EBRT)/Brachytherapy
Description:
External Beam Radiotherapy (EBRT)/Brachytherapy
Arm group label:
SHR-1316 plus concurrent chemoradiotherapy
Summary:
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 .
Criteria for eligibility:
Criteria:
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
200433
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaohua Wu
Phone:
13601772486
Email:
wu.xh@fudan.edu.cn
Start date:
March 20, 2024
Completion date:
January 31, 2025
Lead sponsor:
Agency:
Shanghai Shengdi Pharmaceutical Co., Ltd
Agency class:
Industry
Source:
Shanghai Shengdi Pharmaceutical Co., Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06237257
