- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05357846
PD-1 Inhibitor Combined With Neoadjuvant Chemoradiotherapy Plus Surgery for Locally Advanced ESCC (NEOCRTEC2101)
Phase III Multicenter Randomized Controlled Trial of PD-1 Inhibitor Combined With Preoperative Concurrent Chemoradiotherapy and Surgery for Locally Advanced Esophageal Squamous Cell Carcinoma (NEOCRTEC2101)
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: HONG YANG, M.D. Ph.D.
- Phone Number: 8602087343 8602087343
- Email: yanghong@sysucc.org.cn
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510060
- Recruiting
- Sun Yat-sen University Cancer Center
-
Contact:
- Hong Yang, Ph.D.,M.D.
- Phone Number: 008613560405144
- Email: yanghong@sysucc.org.cn
-
Contact:
- Jiyang Chen
- Phone Number: 008618826238208
- Email: chenjy1@sysucc.org.cn
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Histologic diagnosis of squamous cell thoracic esophageal carcinoma of Stage T1-4aN1-3M0 or T3-4aN0M0,which is potentially resectable.
- Patients must not have received any prior anticancer therapy.
- More than 6 months of expected survival.
- Age ranges from 18 to 70 years.
- Absolute white blood cells count ≥4.0×109/L, neutrophil ≥1.5×109/L, platelets ≥100.0×109/L, hemoglobin ≥90g/L, and normal functions of liver and kidney.
- WHO PS score 0-1
- Signed informed consent document on file.
Exclusion Criteria:
- Patients have received any prior anticancer therapy.
- Patients are diagnosed or suspected to be allergic to sintilimab,toxal or cisplatin.
- Patients with concomitant hemorrhagic disease.
- Patients who cannot tolerate surgery.
- Pregnant or breast feeding.
- Patients without informed consent because of psychological, family, social or any other factors.
- Patients with concomitant peripheral neuropathy, whose CTC status is 2 or even more.
- Patients with malignant tumors other than esophageal cancer,except for non-melanoma skin cancer, in situ cervical cancer, or cured early prostate cancer.
- Patients with history of diabetes over 10 years and unsatisfactory glycemic control.
- Patients with severe heart,lung,liver,renal dysfunction, hematopoietic system diseases, immune system diseases, cachexia or other diseases that lead to intolerance of chemoradiotherapy or surgery.
- Patients with history of autoimmune diseases, immunodeficiency, or organ and allogeneic bone marrow transplantation.
- Patients with history of interstitial lung disease or noninfectious pneumonia.
- Patients with active pulmonary tuberculosis infection, or a history of active pulmonary tuberculosis infection within one year before enrollment, or a history of active pulmonary tuberculosis infection more than one year ago without regular treatment.
- Patients with active hepatitis B ( HBV DNA ≥ 2000 IU / mL or 104 copies / mL ) or hepatitis C ( HCV antibody positive ).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: NCRT+IO group
• NCRT+IO group consists of the PD-1 inhibitor combined with concurrent chemoradiotherapy prior to surgery. The patient will receive 4 weeks of radiation therapy. The radiation will generally commence on the 1st day of treatment and will run for 4 weeks.PD-1 inhibitor is given by intravenous infusion on days 1 and 22. Chemotherapy is given by intravenous infusion on days 1, 8, 15, and 22. Interventions:
|
Sintilimab 200mg, IV (in the vein) on day 1 and day 22
External radiation with a total dose of 40.0 or 45.0 Gy is given in 20 fractions,5 fractions a week.
50mg/m2, IV (in the vein) on day 1,day 8,day 15 and day 22
Other Names:
25mg/m2,IV DRIP on day 1,day 8,day 15 and day 22
Other Names:
McKeown esophagectomy, Ivor Lewis esophagectomy or minimally invasive esophagectomy will be performed 6-8 weeks after chemoradiotherapy.
Two-field lymphadenectomy with total mediastinal lymph node dissection is performed during surgery.
|
Active Comparator: NCRT group
• NCRT group consists of the concurrent chemoradiotherapy prior to surgery. The patient will receive 4 weeks of radiation therapy. The radiation will generally commence on the 1st day of treatment and will run for 4 weeks. Chemotherapy is given by intravenous infusion on days 1, 8, 15, and 22. Interventions:
|
External radiation with a total dose of 40.0 or 45.0 Gy is given in 20 fractions,5 fractions a week.
50mg/m2, IV (in the vein) on day 1,day 8,day 15 and day 22
Other Names:
25mg/m2,IV DRIP on day 1,day 8,day 15 and day 22
Other Names:
McKeown esophagectomy, Ivor Lewis esophagectomy or minimally invasive esophagectomy will be performed 6-8 weeks after chemoradiotherapy.
Two-field lymphadenectomy with total mediastinal lymph node dissection is performed during surgery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival
Time Frame: At end of enrollment- up to 5 years in follow up
|
Overall survival will be calculated from the date of randomization and an event registered on the date of death from any cause.
Patients lost to follow up, or those with no death recorded on the day the database is frozen, will be censored on the date of last follow up.
|
At end of enrollment- up to 5 years in follow up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression free survival
Time Frame: At end of enrollment- up to 5 years in follow up
|
Progression free survival is defined as the time from randomization until objective tumor progression or death.
|
At end of enrollment- up to 5 years in follow up
|
Pathologic complete response rate
Time Frame: Two weeks after surgery
|
No malignant tumor cells were detected in the removed specimens including primary tumor and lymph nodes
|
Two weeks after surgery
|
R0 resection rate
Time Frame: Two weeks after surgery
|
The percentage of patients who undergo complete resection
|
Two weeks after surgery
|
Incidence of perioperative complications
Time Frame: Ninety days after surgery
|
Incidence of complications
|
Ninety days after surgery
|
Perioperative mortality
Time Frame: Ninety after surgery
|
Incidence of death postoperatively
|
Ninety after surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: HONG YANG, Sun Yat-sen University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Head and Neck Neoplasms
- Esophageal Diseases
- Carcinoma
- Esophageal Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Paclitaxel
- Cisplatin
Other Study ID Numbers
- NEOCRTEC2101
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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