TDLN-sparing RT Plus Immunotherapy and Chemotherapy in Locally Advanced ESCC

NCT06676449 | Recruiting Phase 3

• 1 other identifier: ESO-Shanghai 26
• Study Type: interventional
• Target: 432
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if immunotherapy in combination with tumor draining lymph nodes-sparing radiotherapy (TDLN-sparing RT) and chemotherapy works to treat locally advanced esophageal squamous cell cancer in adults. Researchers will compare immunotherapy in combination with TDLN-sparing RT and chemotherapy to TDLN-sparing RT and chemotherapy to see if immunotherapy works more effectively when using TDLN-sparing RT to treat locally advanced esophageal squamous cell cancer Participants will: TDLN-sparing RT for esophageal cancer 50.4Gy/28Fx Paclitaxel plus cisplatin every 3 weeks for 4 cycles PD-1 inhibitors or observation every 3 weeks for 1 year

Conditions

Esophageal Carcinoma; Radiotherapy; Immunotherapy

Outcome Measures

Primary Outcomes (2)

• PFS for patients with TDLN V15 ≤ 50%

  2 years

• PFS for all patients

  2 years

Secondary Outcomes (3)

• OS for patients with TDLN V15 ≤ 50%

  2 years

• OS for all patients

  2 years

• Adverse events

  up to 2 years

Study Arms (2)

Concurrent Immunotherapy plus TDLN-sparing RT and Chemotherapy

EXPERIMENTAL

PD-1 inhibitors will be administered intravenously, a fixed dose of 200 mg, once every 3 weeks for 1 year. Paclitaxel 135mg/m2 d1, cisplatin 25mg/m2 d1-3, once every 3 weeks for 4 cycles, or other guideline recommended regimens for 4 cycles. TDLN-sparing radiotherapy 50.4Gy/28Fx.

Drug: Immunotherapy; Drug: chemotherapy: Paclitaxel/Cisplatin or other guideline recommended regimens; Radiation: TDLN-sparing RT

TDLN-sparing RT and Chemotherapy

ACTIVE COMPARATOR

Paclitaxel 135mg/m2 d1, cisplatin 25mg/m2 d1-3, once every 3 weeks for 4 cycles, or other guideline recommended regimens for 4 cycles. TDLN-sparing radiotherapy 50.4Gy/28Fx. It is allowed to accept immunotherapy followed by radiotherapy.

Drug: chemotherapy: Paclitaxel/Cisplatin or other guideline recommended regimens; Radiation: TDLN-sparing RT

Interventions

Immunotherapy DRUG

PD-1 inhibitors will be administered intravenously, a fixed dose of 200 mg, once every 3 weeks for 1 year.

Concurrent Immunotherapy plus TDLN-sparing RT and Chemotherapy

TDLN-sparing RT RADIATION

TDLN-sparing radiotherapy 50.4Gy/28Fx.

Concurrent Immunotherapy plus TDLN-sparing RT and Chemotherapy; TDLN-sparing RT and Chemotherapy

chemotherapy: Paclitaxel/Cisplatin or other guideline recommended regimens DRUG

Paclitaxel 135mg/m2 d1, cisplatin 25mg/m2 d1-3, once every 3 weeks for 4 cycles. or other guideline recommended regimens

Concurrent Immunotherapy plus TDLN-sparing RT and Chemotherapy; TDLN-sparing RT and Chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent
• Aged 18-75 years
• Histologically confirmed esophageal squamous cell carcinoma
• Clinical stages T2-4N0M0 or TxN+M0 or TxNxM1 (Only for supraclavicular lymph nodes metastasis) based on the 8th UICC-TNM classification
• \. Eastern Cooperative Oncology Group(ECOG) performance status: 0-1 8. Life expectancy ≥3 months 9. Adequate organ functions Absolute neutrophil counts (ANC) ≥1.5×109⁄L; Hemoglobin (Hb) ≥9g⁄dl; Platelet (Plt) ≥100×109⁄L; Total bilirubin ≤1.5 upper limit of normal (ULN); Aspartate transaminase (AST) ≤2.5 ULN; Alanine aminotransferase (ALT) ≤2.5 ULN; Creatinine ≤1.5 ULN 10.Received no more than 3 cycles immunotherapy and/or chemotherapy

You may not qualify if:

• Esophageal perforation or hematemesis
• Any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism and hypothyroidism (effective hormone replacement therapy excepted)) and immunosuppressive agents or systemic hormonal therapy indicated within 28 days (for adverse events of chemoradiotherapy excepted).
• Allergic to macromolecular protein preparations, or to any of the ingredients in PD-1 inhibitors for injection.
• Uncontrolled heart diseases or clinical symptoms, such as: (1) New York Heart Association(NYHA) class II or higher heart failure; (2) unstable angina; (3) myocardial infarction within 1 year; (4)clinically significant arrhythmia requiring clinical intervention.
• Congenital or acquired immunodeficiency (such as HIV infection); active hepatitis B (HBV-DNA≥104 copy number/ml) or hepatitis C (positive hepatitis C antibody, and HCV-RNA is higher than the detection limit of the analytical method); active tuberculosis.
• Active infection or unexplained fever \>38.5 °C within 2 weeks before randomization (fever due to tumor excepted, according to investigator).
• Patients with fertility reluctant to take contraceptive measures during the trial, or female patients pregnant or breastfeeding.
• According to the investigator, other factors that may cause termination of the study. ie, other serious diseases (including mental illness) require combined treatment, family or social factors, which may affect the safety or the collection of trial data.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Immunotherapy; Cisplatin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Immunomodulation; Biological Therapy; Therapeutics; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Central Study Contacts

Dashan Zhao

CONTACT

+862164175590; kuaile_z@sina.com

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: November 5, 2024
• First Posted: November 6, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): October 31, 2028
• Study Completion (Estimated): October 30, 2030
• Last Updated: January 7, 2026

Record last verified: 2026-01

Locations

CN (1)