PD-1 Inhibitor Combined With Neoadjuvant Chemoradiotherapy Plus Surgery for Locally Advanced ESCC (NEOCRTEC2101)

NCT05357846 | Recruiting Phase 3 DMC

• 1 other identifier: NEOCRTEC2101
• Study Type: interventional
• Target: 422
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective is to compare PD-1 inhibitor combined with preoperative chemoradiotherapy followed by surgery versus neo-adjuvant chemoradiotherapy followed by surgery, in terms of the overall survival time (OS) in patients with Stage T1-4aN1-3M0 or T3-4aN0M0 squamous cell esophageal carcinoma.

Conditions

Squamous Cell Esophageal Carcinoma; Esophageal Cancer; Oesophageal Cancer

Outcome Measures

Primary Outcomes (1)

• Overall survival

  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 Outcomes (5)

• Progression free survival

  At end of enrollment- up to 5 years in follow up

• Pathologic complete response rate

  Two weeks after surgery

• R0 resection rate

  Two weeks after surgery

• Incidence of perioperative complications

  Ninety days after surgery

• Perioperative mortality

  Ninety after surgery

Study Arms (2)

NCRT+IO group

EXPERIMENTAL

• 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

Drug: Sintilimab; Radiation: Preoperative radiotherapy; Drug: Paclitaxel; Drug: Cisplatin; Procedure: esophagectomy

NCRT group

ACTIVE COMPARATOR

• 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

Radiation: Preoperative radiotherapy; Drug: Paclitaxel; Drug: Cisplatin; Procedure: esophagectomy

Interventions

Sintilimab DRUG

Sintilimab 200mg, IV (in the vein) on day 1 and day 22

NCRT+IO group

Preoperative radiotherapy RADIATION

External radiation with a total dose of 40.0 or 45.0 Gy is given in 20 fractions,5 fractions a week.

NCRT group; NCRT+IO group

Paclitaxel DRUG

50mg/m2, IV (in the vein) on day 1,day 8,day 15 and day 22

Also known as: Taxol

NCRT group; NCRT+IO group

Cisplatin DRUG

25mg/m2,IV DRIP on day 1,day 8,day 15 and day 22

Also known as: DDP

NCRT group; NCRT+IO group

esophagectomy PROCEDURE

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+IO group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 ).

Sponsors & Collaborators

• Affiliated Cancer Hospital of Shantou University Medical College: collaborator
• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma; Esophageal Neoplasms

Interventions

sintilimab; Paclitaxel; Cisplatin; Esophagectomy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• HONG YANG

  Sun Yat-Sen University Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

HONG YANG, M.D. Ph.D.

CONTACT

8602087343; yanghong@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: March 22, 2022
• First Posted: May 3, 2022
• Study Start: November 1, 2022
• Primary Completion (Estimated): January 1, 2031
• Study Completion (Estimated): January 31, 2031
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

CN (1)