Esophageal Squamous Cell Carcinoma
Conditions
Keywords
Toripalimab, Neoadjuvant, Concurrent Chemoradiotherapy, Esophageal Squamous Cell Carcinoma
Brief summary
This Phase II non-randomized study is to determine the efficacy and toxicity of neoadjuvant toripalimab plus chemotherapy followed by chemoradiotherapy for locally advanced unresectable esophageal squamous cell carcinoma.
Detailed description
This Phase II non-randomized study is to determine the efficacy and toxicity of neoadjuvant toripalimab plus chemotherapy followed by chemoradiotherapy for locally advanced unresectable esophageal squamous cell carcinoma. All patients were planned to receive 2 cycle of toripalimab plus paclitaxel/nedaplatin as neoadjuvant therapy. Then they all receive radical dose of chest radiation and concurrent chemotherapy of capecitabine (PO 1000 mg/m2, bid, d1-d14, q3w).
Interventions
DRUGToripalimab
Toripalimab 240 mg, d1, Q3w for two cycles
Paclitaxel-albumin 260 mg/m2, d1, Q3w for two cycles
DRUGNedaplatin
Nedaplatin 75mg/m2, d1, Q3w for two cycles
RADIATIONradiation therapy at a total dose 60 Gy
Radiation therapy at a total dose 60 Gy
DRUGCapecitabine
Capecitabine 1000 mg/m2, bid, d1-14, q3w during radiotherapy
RADIATIONradiation therapy at a total dose 50 Gy
Radiation therapy at a total dose 50 Gy
Sponsors
Sun Yat-sen University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* histologically confirmed esophageal squamous cell carcinoma * patients have measurable or evaluable lesions based on the Response Evaluation Criteria in Solid Tumors (RECIST) criteria * unresectable T1-4 N0-3 M0-1 confirmed by CT or MRI (M1 only includes patients with lymph node metastasis in the supraclavicular region) * ECOG performance status 0-1 * no previous chest radiotherapy, immunotherapy or biotherapy. * hemoglobin≥10 mg/dL, platelet≥100000/μL,absolute neutrophil count ≥1500/μL * serum creatinine ≤1.25 times the upper normal limit(UNL), or creatinine clearance≥60 ml/min * bilirubin ≤1.5 times UNL, AST（SGOT）≤2.5 times UNL ,ALT（SGPT）≤2.5 times UNL,alkaline phosphatase ≤5 times UNL * FEV1 \>0.8 L * CB6 within normal limits * patients and their family signed the informed consents
Exclusion criteria
* previous or recent another malignancy, except for nonmelanoma skin cancer or cervical cancer in situ * contraindication for chemotherapy * women in pregnancy, lactation period, or no pregnancy test 14 days before the first dose * women who has the probability of pregnancy without contraception * tendency of hemorrhage * in other clinical trials within 30 days * addicted in drugs or alcohol, AIDS patients * uncontrollable seizure or psychotic patients without self-control ability * severe allergy or idiosyncrasy * not suitable for this study judged by researchers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival rate | 18-month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical response rate | 2 months after radiotherapy | the percentage of patients who had partial remission or complete remission after therapy |
| the rate of grade 3 or 4 toxicities according to CTCAE4.0 | 1 year after therapy | the percentage of patients who develop grade 3 or 4 toxicities |
| overall survival rate | 18-month | — |
| locoregional recurrence-free survival | 18-month | — |
| Quality of life assessed by QLQ-C30 | 12 months | — |
| distant metastasis-free survival | 18-month | — |
Countries
China
Outcome results
None listed