Actively Recruiting
Phase III Multicenter Randomized Trial of PD-1 Inhibitor With Preoperative Chemoradiotherapy and Surgery for Locally Advanced Esophageal Squamous Cell Carcinoma
Led by Sun Yat-sen University · Updated on 2026-04-30
422
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
Sponsors
S
Sun Yat-sen University
Lead Sponsor
A
Affiliated Cancer Hospital of Shantou University Medical College
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are comparing a PD-1 inhibitor combined with preoperative chemoradiotherapy followed by surgery to neoadjuvant chemoradiotherapy followed by surgery in patients with locally advanced squamous cell esophageal carcinoma (ESCC). The study focuses on patients with Stage T1-4aN1-3M0 or T3-4aN0M0 ESCC, aiming to evaluate overall survival time. This Phase III randomized controlled trial is led by Sun Yat-sen University and targets patients aged 18 to 70 years with potentially resectable tumors who have not received prior anticancer therapy. Participants are divided into two groups. The experimental group (NCRT+IO) receives a PD-1 inhibitor called sintilimab by intravenous infusion on days 1 and 22, along with concurrent chemoradiotherapy, which includes radiation (40 or 45 Gy over 4 weeks) and chemotherapy drugs paclitaxel and cisplatin given intravenously on days 1, 8, 15, and 22. The comparator group (NCRT) receives the same chemoradiotherapy without the PD-1 inhibitor. Surgery, consisting of esophagectomy with lymph node dissection, occurs 6 to 8 weeks after chemoradiotherapy. During the study, participants undergo detailed monitoring including evaluation of overall survival over up to 5 years of follow-up. Secondary outcomes include progression-free survival, pathologic complete response rate, R0 resection rate, perioperative complications, and mortality assessed up to 90 days after surgery. Patients are assessed for blood counts, organ function, and general health status before and during treatment. The study ensures careful follow-up to measure treatment effects and safety outcomes over an extended period.
CONDITIONS
Brief Title
PD-1 Inhibitor Combined With Neoadjuvant Chemoradiotherapy Plus Surgery for Locally Advanced ESCC (NEOCRTEC2101)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologic diagnosis of squamous cell thoracic esophageal carcinoma of Stage T1-4aN1-3M0 or T3-4aN0M0, potentially resectable
- No prior anticancer therapy received
- Expected survival of more than 6 months
- Age between 18 and 70 years
- Adequate blood counts and normal liver and kidney function
- WHO performance status score of 0-1
- Signed informed consent document on file
You will not qualify if you...
- Prior anticancer therapy received
- Allergy or suspected allergy to sintilimab, paclitaxel, or cisplatin
- Concomitant hemorrhagic disease
- Unable to tolerate surgery
- Pregnant or breastfeeding
- Lack of informed consent due to psychological, family, social, or other factors
- Peripheral neuropathy with CTC grade 2 or higher
- Other malignant tumors except certain skin, cervical, or prostate cancers
- Diabetes over 10 years with poor control
- Severe heart, lung, liver, renal dysfunction, hematopoietic or immune system diseases, cachexia, or other conditions preventing treatment
- History of autoimmune diseases, immunodeficiency, or organ/bone marrow transplantation
- History of interstitial lung disease or noninfectious pneumonia
- Active or recent pulmonary tuberculosis infection without treatment
- Active hepatitis B or hepatitis C infection with specified viral load limits
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants receive concurrent chemoradiotherapy with or without PD-1 inhibitor prior to surgery. This includes 4 weeks of radiation therapy given in 20 fractions, chemotherapy infusions on days 1, 8, 15, and 22, and for some participants, PD-1 inhibitor infusions on days 1 and 22.
Weekly visits for 4 weeks
Duration - 6 to 8 weeks after treatment
Participants undergo esophagectomy surgery approximately 6 to 8 weeks after completing chemoradiotherapy, followed by immediate post-operative care including lymphadenectomy.
1 surgical hospitalization
Duration - Up to 90 days after surgery
Participants are monitored for recovery and any complications after surgery, including assessments for pathologic response and perioperative outcomes.
Approximately 3 follow-up visits
Duration - Up to 5 years
Participants are followed for overall survival and progression-free survival outcomes.
Periodic follow-up visits during 5 years
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
H
HONG YANG, M.D. Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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