Clinical trial NCT06237257: A Study of Chemoradiotherapy With SHR-1316 For Treatment of Locally Advanced Cervical Cancer
Official title: A Study of Chemoradiotherapy With SHR-1316 For Treatment of Locally Advanced Cervical Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Locally Advanced Cervical Cancer
Lead sponsor: Shanghai Shengdi Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2024-02-01
Enrollment: 56
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 .


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.

Primary outcomes:
measure: Type, incidence and grade of drug-related adverse events of grade 3 and above
timeFrame: Up to approximately 24 months
Secondary outcomes:
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
measure: Rate of Suspension and Discontinuation Due to an Adverse Event correlation with study drug
timeFrame: Up to approximately 30 months
measure: Objective Response Rate(ORR)
timeFrame: Up to approximately 60 months
measure: Duration of response (DoR)
timeFrame: Up to approximately 60 months
measure: Progression free survival (PFS)
timeFrame: Up to approximately 60 months
measure: Overall Survival (OS)
timeFrame: Up to approximately 60 months
measure: 2-year Progression free survival
timeFrame: Up to approximately 24 months
measure: 3-year Overall Survival
timeFrame: Up to approximately 36 months
measure: 12-week Complete Response
timeFrame: Up to approximately 4 months
measure: PK traits of SHR-1316: Cmax
timeFrame: Up to approximately 24 months
measure: PK traits of SHR-1316: Tmax
timeFrame: Up to approximately 24 months
measure: PK traits of SHR-1316: AUC0-t
timeFrame: Up to approximately 24 months
measure: PK traits of SHR-1316: AUC0-∞
timeFrame: Up to approximately 24 months
measure: PK traits of SHR-1316: t1/2
timeFrame: Up to approximately 24 months
measure: PK traits of SHR-1316: CL
timeFrame: Up to approximately 24 months
measure: PK traits of SHR-1316: Vss
timeFrame: Up to approximately 24 months
measure: Serum concentration of SHR-1316 at each planned blood collection time point
timeFrame: Up to approximately 24 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
References: