Last updated: February 7, 2024
Sponsor: Sun Yat-sen University
Overall Status: Active - Not Recruiting
Phase
2
Condition
Esophageal Disorders
Squamous Cell Carcinoma
Lung Cancer
Treatment
radiation therapy at a total dose 50 Gy
Toripalimab
radiation therapy at a total dose 60 Gy
Clinical Study ID
NCT04844385
GASTO-1071
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- histologically confirmed esophageal squamous cell carcinoma
- patients have measurable or evaluable lesions based on the Response EvaluationCriteria in Solid Tumors (RECIST) criteria
- unresectable T1-4 N0-3 M0-1 confirmed by CT or MRI (M1 only includes patients withlymph 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≥60ml/min
- bilirubin ≤1.5 times UNL, AST(SGOT)≤2.5 times UNL ,ALT(SGPT)≤2.5 times UNL,alkalinephosphatase ≤5 times UNL
- FEV1 >0.8 L
- CB6 within normal limits
- patients and their family signed the informed consents
Exclusion
Exclusion Criteria:
- previous or recent another malignancy, except for nonmelanoma skin cancer or cervicalcancer in situ
- contraindication for chemotherapy
- women in pregnancy, lactation period, or no pregnancy test 14 days before the firstdose
- 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
Study Design
Total Participants: 124
Treatment Group(s): 6
Primary Treatment: radiation therapy at a total dose 50 Gy
Phase: 2
Study Start date:
February 20, 2021
Estimated Completion Date:
December 20, 2024
Study Description
Connect with a study center
Sun yat-sen University Cancer Center
Guangzhou, Guangdong 510000
ChinaSite Not Available

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