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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06237257
Other study ID # SHR-1316-202
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date March 20, 2024
Est. completion date January 31, 2025

Study information

Verified date April 2024
Source Shanghai Shengdi Pharmaceutical Co., Ltd
Contact Yong Cao
Phone +0518-81220121
Email caoyong@hrs.com.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 .


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date January 31, 2025
Est. primary completion date November 30, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 75 Years
Eligibility 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.

Study Design


Intervention

Biological:
SHR-1316
SHR-1316(Adebrelimab Injection)
Drug:
Cisplatin Injection/Carboplatin Injection
Cisplatin Injection/Carboplatin Injection
Radiation:
External Beam Radiotherapy (EBRT)/Brachytherapy
External Beam Radiotherapy (EBRT)/Brachytherapy

Locations

Country Name City State
China Fudan University Shanghai Cancer Center Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Shengdi Pharmaceutical Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Type, incidence and grade of drug-related adverse events of grade 3 and above Up to approximately 24 months
Secondary Adverse events (AEs) include incidence, grade (judged according to NCI-CTCAE V5.0 standards), duration and correlation with study drugs Up to approximately 30 months
Secondary Rate of Suspension and Discontinuation Due to an Adverse Event correlation with study drug Up to approximately 30 months
Secondary Objective Response Rate(ORR) judged based on RECIST 1.1 criteria according to Investigator's assessment Up to approximately 60 months
Secondary Duration of response (DoR) judged based on RECIST 1.1 criteria according to Investigator's assessment Up to approximately 60 months
Secondary Progression free survival (PFS) judged based on RECIST 1.1 criteria according to Investigator's assessment Up to approximately 60 months
Secondary Overall Survival (OS) judged based on RECIST 1.1 criteria according to Investigator's assessment Up to approximately 60 months
Secondary 2-year Progression free survival judged based on RECIST 1.1 criteria according to Investigator's assessment Up to approximately 24 months
Secondary 3-year Overall Survival judged based on RECIST 1.1 criteria according to Investigator's assessment Up to approximately 36 months
Secondary 12-week Complete Response judged based on RECIST 1.1 criteria according to Investigator's assessment Up to approximately 4 months
Secondary PK traits of SHR-1316: Cmax Up to approximately 24 months
Secondary PK traits of SHR-1316: Tmax Up to approximately 24 months
Secondary PK traits of SHR-1316: AUC0-t Up to approximately 24 months
Secondary PK traits of SHR-1316: AUC0-8 Up to approximately 24 months
Secondary PK traits of SHR-1316: t1/2 Up to approximately 24 months
Secondary PK traits of SHR-1316: CL Up to approximately 24 months
Secondary PK traits of SHR-1316: Vss Up to approximately 24 months
Secondary Serum concentration of SHR-1316 at each planned blood collection time point Up to approximately 24 months
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