Esophageal Squamous Cell Cancer
Conditions
Keywords
Esophageal Squamous Cell Cancer, PD-L1, TGF-β, Retlirafusp Alfa, SHR-1701, concurrent chemoradiotherapy
Brief summary
The goal of this clinical trial is to evaluate the efficacy and safety of retlirafusp alfa combined with radical chemoradiotherapy in the treatment of locally advanced unresectable esophageal squamous cell carcinoma. Participants will receive two cycles of retlirafusp alfa and chemotherapy for induction therapy before standard concurrent chemoradiotherapy and retlirafusp alfa for maintenance treatment till one year.
Interventions
Participants will receive two cycles of retlirafusp alfa and chemotherapy for induction therapy: Retlirafusp alfa 1800mg Day1 + Albumin-bound paclitaxel 125mg/m² Day 1 and Day 8 + Cisplatin 25mg/m² Day 1-3 every 3 weeks (Q3w)
RADIATIONConcurrent chemoradiotherapy (cCRT)
Radiation: 1.8Gy/Fx, total dose (DT) 50.4Gy/28Fx; Chemotherapy: Albumin-bound paclitaxel 60-80mg/m² + Cisplatin 25mg/m² Day 1 every week (Qw)
DRUGmaintenance immunotherapy
Retlirafusp Alfa 1800 mg on Day 1, Q3W, as maintenance therapy until disease progression or unacceptable toxicity, for up to 1 year; the total number of cycles for Retlirafusp Alfa induction and maintenance therapy should not exceed 15 cycles.
Sponsors
RenJi Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Voluntarily sign the written informed consent form and agree to participate in this study; 2. Pathologically confirmed esophageal squamous cell carcinoma; 3. Staged as T2-4bN0-3M0 or TXNXM1 (with supraclavicular lymph node metastasis), diagnosed as unresectable locally advanced esophageal cancer (according to the American Joint Committee on Cancer (AJCC) 8th edition); 4. Aged 18-75 years, male or female; 5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1; 6. No prior anti-tumor therapy for esophageal cancer, including radiotherapy, chemotherapy, surgery, etc.; 7. Adequate major organ function, meeting the following laboratory criteria: Complete blood count: Neutrophil count ≥ 1.5 × 10⁹/L; Platelet count ≥ 100 × 10⁹/L; Hemoglobin ≥ 90 g/L; Blood biochemistry: Total bilirubin ≤ 1.5 × upper limit of normal (ULN); ALT ≤ 2.5 × ULN, AST ≤ 2.5 × ULN; Serum creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 50 mL/min; Coagulation function: International normalized ratio (INR) ≤ 1.5 × ULN; Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; 8. Female patients of childbearing potential must have a negative serum pregnancy test within 72 hours prior to the first dose of study drug, and must use effective contraception during the study period and for at least 3 months after the last dose; Male patients with female partners of childbearing potential must be surgically sterile or agree to use effective contraception during the study period and for 3 months after the last dose.
Exclusion criteria
1. Prior or concurrent treatment with any of the following: 1. Any prior or ongoing radiotherapy, chemotherapy, or other anti-tumor agents for malignancy; 2. Use of immunosuppressive agents or systemic corticosteroids for immunosuppressive purposes (at a dose \> 10 mg/day of prednisone or equivalent) within 2 weeks prior to the first dose of study drug. Inhaled or topical corticosteroids, and adrenal hormone replacement at doses \> 10 mg/day prednisone or equivalent, are permitted in the absence of active autoimmune disease; 3. Receipt of live attenuated vaccines within 4 weeks prior to the first dose of study drug; 4. Major surgery or severe trauma within 4 weeks prior to the first dose of study drug; 2. Tumor-related
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1 year progression-free survival (PFS) rate | From the date of first study treatment administration until the date of first documented progression or death from any cause, whichever comes first, assessed up to 1 year (12 months). | Progression-free survival (PFS) is defined as the time from the date of first study treatment administration to the first documented disease progression (per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)) or death from any cause, whichever occurs first. The 1-year PFS rate is the proportion of participants who are alive and progression-free at 1 year (12 months) after the first dose. |
Countries
China
Contacts
CONTACTXiumei Ma
Outcome results
None listed