Locally Advanced Cervical Cancer
Conditions
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 .
Interventions
BIOLOGICALSHR-1316
SHR-1316（Adebrelimab Injection）
DRUGCisplatin Injection/Carboplatin Injection
Cisplatin Injection/Carboplatin Injection
RADIATIONExternal Beam Radiotherapy (EBRT)/Brachytherapy
External Beam Radiotherapy (EBRT)/Brachytherapy
DRUGPaclitaxel Injection
Paclitaxel Injection.
Sponsors
Shanghai Shengdi Pharmaceutical Co., Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Type, incidence and grade of drug-related adverse events of grade 3 and above | Up to approximately 24 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Rate of Suspension and Discontinuation Due to an Adverse Event correlation with study drug | Up to approximately 30 months | — |
| Objective Response Rate(ORR) | Up to approximately 60 months | judged based on RECIST 1.1 criteria according to Investigator's assessment |
| Duration of response (DoR) | Up to approximately 60 months | judged based on RECIST 1.1 criteria according to Investigator's assessment |
| Progression free survival (PFS) | Up to approximately 60 months | judged based on RECIST 1.1 criteria according to Investigator's assessment |
| 2-year Progression free survival | Up to approximately 24 months | judged based on RECIST 1.1 criteria according to Investigator's assessment |
| 3-year Overall Survival | Up to approximately 36 months | judged based on RECIST 1.1 criteria according to Investigator's assessment |
| 12-week Complete Response | Up to approximately 4 months | judged based on RECIST 1.1 criteria according to Investigator's assessment |
| Overall Survival (OS) | Up to approximately 60 months | judged based on RECIST 1.1 criteria according to Investigator's assessment |
| PK traits of SHR-1316: Tmax | Up to approximately 24 months | — |
| PK traits of SHR-1316: AUC0-t | Up to approximately 24 months | — |
| PK traits of SHR-1316: AUC0-∞ | Up to approximately 24 months | — |
| PK traits of SHR-1316: t1/2 | Up to approximately 24 months | — |
| PK traits of SHR-1316: CL | Up to approximately 24 months | — |
| PK traits of SHR-1316: Vss | Up to approximately 24 months | — |
| Serum concentration of SHR-1316 at each planned blood collection time point | Up to approximately 24 months | — |
| PK traits of SHR-1316: Cmax | Up to approximately 24 months | — |
Countries
China
Outcome results
None listed