Advanced Cervical Cancer
Conditions
Brief summary
This study aims to evaluate the efficacy of Adebrelimab plus concurrent chemoradiotherapy compared with placebo plus concurrent chemoradiotherapy for the treatment of locally advanced cervical cancer by evaluating progression-free survival (PFS).
Interventions
SHR-1316 injection.
DRUGCisplatin Injection
Cisplatin injection.
DRUGCarboplatin Injection
Carboplatin injection.
DRUGPaclitaxel Injection
Paclitaxel injection.
DRUGSHR-1316 Placebo Injection
SHR-1316 placebo injection.
Sponsors
Shanghai Shengdi Pharmaceutical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Participate in the study voluntarily, sign the informed consent form. 2. Subjects were able to provide primary or metastatic cancer samples. 3. At least one measurable lesion. 4. Expected survival \> 3 months. 5. ECOG 0 \ 1. 6. With adequate organ functions.
Exclusion criteria
1. Pathologically or radiologically confirmed presence of distant metastatic disease, including lymph nodes above the first lumbar vertebra (L1) (cephalad) or in the inguinal region. 2. Administering live vaccines within 4 weeks before enrollment or during planned study treatment. 3. Participants who received immunosuppressive therapy within 4 weeks before enrolment. 4. For participants who are receiving thrombolytic/anticoagulant therapy, prophylactic anticoagulant therapy is allowed. 5. Participants who have had other uncured malignant tumors in the past (within 5 years) or concurrently have had other uncured malignant tumors, excluding cured basal cell carcinoma of the skin and carcinoma in situ. 6. Known allergy to the investigational drug or any of its excipients; or severe allergic reaction to other monoclonal antibodies. 7. Pregnant or breastfeeding women. 8. According to the investigator's judgment, there are diseases or any other conditions that may seriously endanger the safety of the subjects, may confound the research results, or affect the subjects' ability to complete the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) | Up to approximately 36 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The second disease progression assessed by the investigator | Up to approximately 60 months. | — |
| Adverse events (AEs) including incidence and grade correlation with study drugs | Up to approximately 60 months. | — |
| Rate of suspension and discontinuation due to an adverse event correlation with study drugs | Up to approximately 60 months. | — |
| Overall survival (OS) | Up to approximately 60 months. | OS is the time interval from the start of treatment to death due to any reason or lost of follow-up. |
| Distant recurrence rate | Up to approximately 60 months. | — |
| 2-year progression-free survival (PFS) | Up to approximately 24 months. | PFS within 2 years. |
| Objective Response Rate (ORR) | Up to approximately 36 months. | — |
| Duration of response (DoR) | Up to approximately 60 months. | — |
| Local progression rate | Up to approximately 36 months. | — |
| 3-year overall survival (OS) rate | Up to approximately 60 months. | OS rate within 3 years. |
Countries
China
Contacts
Primary ContactXiaoxu Zhang
Backup ContactZhaoyu Zhong
Outcome results
None listed