Camrelizumab, Locally Advanced Esophageal Squamous Cell Carcinoma, Neoadjuvant Therapy
Conditions
Brief summary
This study aims to evaluate the efficacy and safety of interferon-gamma combined with camrelizumab plus chemotherapy as neoadjuvant therapy for locally advanced esophageal squamous cell carcinoma. Based on previous mechanistic research and preliminary clinical data, this trial intends to generate high-level evidence for this therapeutic strategy, which may improve the treatment landscape for patients with locally advanced esophageal squamous cell carcinoma.
Interventions
DRUGInterferon-γ
1,000,000 IU administered intravenously on Day 1 of each 3-week cycle for a total of 3-4 cycles.
DRUGCamrelizumab
200 mg administered intravenously on Day 1 of each 3-week cycle for a total of 3-4 cycles.
Sponsors
Hefei Cancer Hospital of the Chinese Academy of Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Aged \>= 18 years; 2. Histologically confirmed esophageal squamous cell carcinoma (ESCC), clinical stage cT1b-3, N+, M0; 3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1; 4. Expected overall survival \> 6 months; 5. Adequate bone marrow, hepatic, renal, coagulation, and thyroid function.
Exclusion criteria
1. Active autoimmune disease; 2. Requirement for systemic immunosuppressive therapy; 3. Hypersensitivity to any study drug; 4. Uncontrolled significant organ disease (e.g., cardiac, pulmonary, hepatic, renal) or active infection; 5. Pregnant or lactating female.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathological complete response rate | At the time of surgical resection. | The proportion of patients achieving pathological complete response (absence of viable tumor cells in primary lesion and regional lymph nodes) evaluated by pathological examination of surgical specimens. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | From date of enrollment until death from any cause, assessed up to 24 months. | Follow-up via outpatient visits or telephone interviews; defined as time from enrollment to death from any cause. |
| Duration of Response | From the date of first documented confirmed response until disease progression or death from any cause, assessed up to 24 months. | Time from first observation of confirmed CR or PR to disease progression or death from any cause, assessed per RECIST Version 1.1. |
| Objective Response Rate | At the end of Cycle 2, Cycle 4, (each cycle is 21 days). | The proportion of participants with confirmed complete response (CR) or partial response (PR) assessed per RECIST 1.1. |
| Progression-free survival | From date of enrollment until the date of first documented progression or death from any cause, whichever came first, assessed up to 24 months. | Time from enrollment to disease progression (per RECIST 1.1) or death from any cause, whichever occurs first. |
Countries
China
Contacts
CONTACTHongzhi Wang
STUDY_CHAIRHongzhi Wang
Hefei Cancer Hospital, Chinese Academy of Sciences
Outcome results
None listed