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Julie R Brahmer, Scott S Tykodi, Laura Q M Chow...
https://pubmed.ncbi.nlm.nih.gov/22658128Actively Recruiting
Phase 2
Age: 18Years - 75Years
All Genders
ID06843889
A Phase II Study of Toripalimab Combined With Sequential Neoadjuvant Chemoradiotherapy in Patients With Esophageal Squamous Cell Carcinoma
Led by Nanfang Hospital, Southern Medical University · Updated on 2025-04-16
34
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating Toripalimab combined with sequential neoadjuvant chemoradiotherapy in patients with resectable local middle and advanced esophageal squamous cell carcinoma. This open phase II clinical study involves 34 patients and aims to assess the effectiveness and safety of this combination treatment by looking at pathological complete response, disease-free survival, overall survival, and adverse reactions. The treatment begins with Phase I, where patients receive Toripalimab (240mg on day 1 every 3 weeks for 2 cycles) combined with a chemotherapy regimen chosen by the investigator. In the second stage, patients receive Toripalimab (240mg on day 1, every 3 weeks for 1 cycle) combined with intensity modulated radiotherapy (40Gy delivered in 20 fractions). Surgery is then performed 4 to 6 weeks after completing the treatments, followed by multidisciplinary team discussions to decide on further therapy. Participants will undergo assessments including pathological evaluation of tumor response after surgery to determine complete and major pathological responses. Researchers will monitor disease-free and overall survival for up to 100 and 120 months respectively, and record adverse events during treatment and an average two-year follow-up. Vital organ functions, imaging, and laboratory tests are used to ensure safety and treatment adherence throughout the study period.
CONDITIONS
Brief Title
A Phase II Study of Toripalimab Combined With Sequential Neoadjuvant Chemoradiotherapy in Patients With Esophageal Squamous Cell Carcinoma
Who Can Participate
Age: 18Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years old, any sex
- Esophageal squamous cell carcinoma confirmed by histopathology
- Thoracic esophageal cancer stages T2-4a, N0-3, M0 (AJCC 8th edition), deemed resectable by surgical evaluation
- No prior anti-tumor therapy, initial treatment patients only
- Expected survival time of at least 6 months
- ECOG performance status 0 or 1
- No history of esophageal perforation, active esophageal bleeding, or obvious invasion of trachea or thoracic large vessels
- Vital organ function within specified limits including blood counts, liver and kidney function
- Forced expiratory volume in 1 second (FEV1) at least 0.8L
- Informed consent signed after understanding trial details
You will not qualify if you...
- Allergy to recombinant humanized anti-PD-1 monoclonal antibody drugs or their components
- Currently receiving other study treatments
- Previous systemic therapy for esophageal cancer including chemotherapy, targeted therapy, or immunotherapy
- Active pulmonary tuberculosis under treatment or treated within 1 year
- Uncontrolled or symptomatic hypercalcemia
- Active uncontrolled infections including acute pneumonia
- Uncontrolled major seizures or superior vena cava syndrome
- Other current or previous malignant tumors except certain treated skin or breast/cervix cancers without recurrence
- History or evidence of significant lung diseases affecting lung function
- Known HIV infection
- Severe cardiovascular disease such as NYHA class 2 or higher heart failure, unstable angina, unstable arrhythmia, or recent heart attack or stroke
- Use of systemic immunosuppressive drugs for autoimmune disease within 2 years
- Live viral vaccine within 4 weeks before study entry
- Prior allogeneic stem cell or solid organ transplantation
- Pregnancy, lactation, or unwillingness to use contraception
- Any other significant disease or condition affecting protocol adherence, consent, or study participation including substance abuse or abnormal lab results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - Approximately 9 weeks (3 cycles of Toripalimab every 3 weeks plus radiotherapy)
Participants receive Toripalimab combined with sequential neoadjuvant chemoradiotherapy, including chemotherapy and radiotherapy before surgery.
Multiple visits for drug administration and radiotherapy sessions
Surgery and Immediate Post-operative Care
Duration - 4 to 6 weeks
Participants undergo surgery 4 to 6 weeks after completing chemoradiotherapy, followed by immediate post-operative care.
1 surgery visit and several post-operative visits
Follow-up
Duration - Up to 2 years of follow-up
Participants are monitored for disease recurrence, survival, and adverse events after surgery and treatment completion.
Regular follow-up visits during the monitoring period
Trial Site Locations
Total: 1 location
1
Nanfang Hospital, Southern Medical University
Guangzhou, Baiyun District, China, 510515
Actively Recruiting
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Research Team
W
Wei Wang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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