Short-course Hypofractionated Radiotherapy in Combination With Raltitrexed and Tislelizumab in Patients With Region-relapsed or Progressive Esophageal Squamous Cell Carcinoma: a Single Arm, Observational Study

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

The goal of this observational study was to explore the safety and efficacy of short course hypofractionated radiotherapy combined with Raltitrexed and Tislelizumab in the treatment of patients with relapsed or advanced esophageal squamous cell carcinoma.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Signing informed consent; ECOG 0-2 points;

• Age over 18 years old, gender is not limited;

• Esophageal squamous cell carcinoma confirmed by pathology or clinically diagnosed by imaging;

• Recurrence of the tumor area after radical surgery or radical chemoradiotherapy; Regional progression of advanced esophageal squamous cell carcinoma after first-line or second-line treatment;

• Clinical staging: regional recurrence (rT0-4N0-3M0-1a) or regional progression (cT0-4N0-3M0-1) (AJCC/UICC esophageal cancer staging (8th edition));

• Tumor lesions can be evaluated;

• Expected survival ≥3 months;

• Major organ function is normal, meeting the following criteria: (i) blood routine examination A.HB ≥90g/L; b.ANC≥1.5×109/L; C. PLT ≥80×109/L; (ii) Biochemical examination: a. ALT/AST≤2.5ULN; b. TBIL≤1.5ULN; c. Plasma Cr≤1.5ULN or creatinine clearance (CCr)≥60ml/min;

• Women of childbearing age must have had a pregnancy within 7 days before starting treatment and the result is negative;

• All enrolled patients should take adequate contraceptive measures throughout the treatment period and 4 weeks after completion;

• no serious hematopoietic function, heart function, endocrine and immune function defects;

• No patients with grade 3 or above other serious medical diseases.

Locations
Other Locations
China
Yuan He
RECRUITING
Hefei
Contact Information
Primary
Yuan He, doctor
heyuan3766@126.com
800-555-5555
Time Frame
Start Date: 2024-03-01
Estimated Completion Date: 2027-03-01
Participants
Target number of participants: 25
Related Therapeutic Areas
Sponsors
Leads: Anhui Provincial Hospital

This content was sourced from clinicaltrials.gov