A Study of Chemoradiotherapy With SHR-1316 For Treatment of Locally Advanced Cervical Cancer

Locally Advanced Cervical Cancer Clinical Trial

Official title:

A Study of Chemoradiotherapy With SHR-1316 For Treatment of Locally Advanced Cervical Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06237257
• Other study ID #: SHR-1316-202
• Status: Recruiting
• Phase: Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Locally Advanced Cervical Cancer
• Uterine Cervical Neoplasms

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