Actively Recruiting
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
173 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This was a single-center, open phase II clinical study. 34 patients with resectable local middle and advanced esophageal squamous cell carcinoma were treated with anti-PD-1 antibody combined with sequential chemoratherapy regimen: Phase I:Toripalimab (240mg day1, Q3W\*2cycle) + clinical routine chemotherapy regimen selected by the investigator; The second stage: Toripalimab (240mg day1, Q3W\*1cycle) + radiotherapy (intensity modulated radiotherapy, 40Gy/20F, 2Gy/F); Surgery was performed 4-6 weeks after completion, and subsequent treatment options were considered after surgery according to MDT discussion. According to the postoperative pathological results, the pathological complete response (pCR) and major response (MPR) were evaluated. The disease-free survival (DFS), overall survival (OS), 1 or 2 years survival rate and adverse reactions were recorded.
CONDITIONS
Official Title
A Phase II Study of Toripalimab Combined With Sequential Neoadjuvant Chemoradiotherapy in Patients With Esophageal Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years, any gender
- Confirmed esophageal squamous cell carcinoma by histopathology
- Thoracic esophageal cancer staged T2-4a, N0-3, M0 and considered resectable by surgery evaluation
- Patients who have not received prior anti-tumor therapy
- Expected survival time of at least 6 months
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- No history of esophageal perforation, active esophageal bleeding, or obvious invasion of trachea or thoracic large vessels
- Adequate vital organ function with specified blood counts and liver and kidney function within normal limits
- Forced expiratory volume in 1 second (FEV1) of at least 0.8 liters
- Provided informed consent after being informed about trial details
You will not qualify if you...
- Allergy to recombinant humanized anti-PD-1 monoclonal antibodies or their components
- Currently participating in another study and receiving treatment
- Previous systemic therapy for esophageal cancer, including chemotherapy, targeted therapy, or immunotherapy
- Active pulmonary tuberculosis under treatment or treated within 1 year before screening
- Uncontrolled or symptomatic hypercalcemia
- Clinically uncontrolled active infections such as acute pneumonia
- Uncontrolled major seizures or superior vena cava syndrome
- History or current presence of other malignant tumors except certain treated skin, breast, cervical, or bladder cancers
- History of interstitial pneumonia, idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonia, or other severe lung diseases affecting lung function
- Known HIV infection
- Severe cardiovascular disease such as NYHA class 2 or higher heart failure, unstable angina, unstable arrhythmia, recent myocardial infarction or stroke within 6 months
- Use of systemic immunosuppressive drugs for active autoimmune disease within 2 years
- Receipt of live viral vaccine within 4 weeks before study entry
- Prior allogeneic stem cell or solid organ transplantation
- Pregnant or breastfeeding women, women who may become pregnant without contraceptive measures, or partners unwilling to use contraception
- Any other significant disease or condition that might interfere with study participation or benefit, including psychosis, substance abuse, abnormal labs, diverticulitis, intra-abdominal abscess, intestinal obstruction, or peritoneal carcinomatosis
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Trial Site Locations
Total: 1 location
1
Nanfang Hospital, Southern Medical University
Guangzhou, Baiyun District, China, 510515
Actively Recruiting
Research Team
W
Wei Wang
CONTACT
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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