PD-1 Inhibitor Combined With Neoadjuvant Chemoradiotherapy Plus Surgery for Locally Advanced ESCC (NEOCRTEC2101)
NCT ID: NCT05357846
Last Updated: 2025-06-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
422 participants
INTERVENTIONAL
2022-11-01
2031-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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:
* Radiation: (40 or 45 Gy/20 fractions)
* Drug: Sintilimab
* Drug: Paclitaxel
* Drug: Cisplatin
Sintilimab
Sintilimab 200mg, IV (in the vein) on day 1 and day 22
Preoperative radiotherapy
External radiation with a total dose of 40.0 or 45.0 Gy is given in 20 fractions,5 fractions a week.
Paclitaxel
50mg/m2, IV (in the vein) on day 1,day 8,day 15 and day 22
Cisplatin
25mg/m2,IV DRIP on day 1,day 8,day 15 and day 22
esophagectomy
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.
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:
* Radiation: (40 or 45 Gy/20 fractions)
* Drug: Paclitaxel
* Drug: Cisplatin
Preoperative radiotherapy
External radiation with a total dose of 40.0 or 45.0 Gy is given in 20 fractions,5 fractions a week.
Paclitaxel
50mg/m2, IV (in the vein) on day 1,day 8,day 15 and day 22
Cisplatin
25mg/m2,IV DRIP on day 1,day 8,day 15 and day 22
esophagectomy
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.
Interventions
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Sintilimab
Sintilimab 200mg, IV (in the vein) on day 1 and day 22
Preoperative radiotherapy
External radiation with a total dose of 40.0 or 45.0 Gy is given in 20 fractions,5 fractions a week.
Paclitaxel
50mg/m2, IV (in the vein) on day 1,day 8,day 15 and day 22
Cisplatin
25mg/m2,IV DRIP on day 1,day 8,day 15 and day 22
esophagectomy
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients must not have received any prior anticancer therapy.
3. More than 6 months of expected survival.
4. Age ranges from 18 to 70 years.
5. 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.
6. WHO PS score 0-1
7. Signed informed consent document on file.
Exclusion Criteria
2. Patients are diagnosed or suspected to be allergic to sintilimab,toxal or cisplatin.
3. Patients with concomitant hemorrhagic disease.
4. Patients who cannot tolerate surgery.
5. Pregnant or breast feeding.
6. Patients without informed consent because of psychological, family, social or any other factors.
7. Patients with concomitant peripheral neuropathy, whose CTC status is 2 or even more.
8. Patients with malignant tumors other than esophageal cancer,except for non-melanoma skin cancer, in situ cervical cancer, or cured early prostate cancer.
9. Patients with history of diabetes over 10 years and unsatisfactory glycemic control.
10. 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.
11. Patients with history of autoimmune diseases, immunodeficiency, or organ and allogeneic bone marrow transplantation.
12. Patients with history of interstitial lung disease or noninfectious pneumonia.
13. 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.
14. Patients with active hepatitis B ( HBV DNA ≥ 2000 IU / mL or 104 copies / mL ) or hepatitis C ( HCV antibody positive ).
18 Years
70 Years
ALL
No
Sponsors
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Affiliated Cancer Hospital of Shantou University Medical College
OTHER
Sun Yat-sen University
OTHER
Responsible Party
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Yang Hong
Prof.
Principal Investigators
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HONG YANG
Role: PRINCIPAL_INVESTIGATOR
Sun Yat-sen University
Locations
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Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NEOCRTEC2101
Identifier Type: -
Identifier Source: org_study_id
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