TDLN-sparing RT Followed by PD-1 Inhibitor Maintenance Therapy in Locally Advanced ESCC

Phase 3

Recruiting

• Conditions: Esophageal Carcinoma; Radiotherapy; Immunotherapy
• Interventions: Drug: PD-1 inhibitor; Radiation: Unlimited radiotherapy; Radiation: TDLN-sparing radiotherapy

• Registration Number: NCT06964568
• Lead Sponsor: Fudan University

Brief Summary

The goal of this clinical trial is to learn if tumor draining lymph nodes-sparing radiotherapy (TDLN-sparing RT) followed by immunotherapy as maintenance therapy works to treat locally advanced esophageal squamous cell cancer in adults.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-02-01
• Status Verified: 2025-05
• Study First Submitted: 2025-05-01
• Study First Submitted QC: 2025-05-01
• Last Update Submitted: 2025-05-01
• Study First Posted: 2025-05-09
• Last Update Posted: 2025-05-09
• Primary Completion: 2029-02
• Study Completion: 2031-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 452

Inclusion Criteria

1. Written informed consent

2. Aged 18 years or above

3. Histologically confirmed esophageal squamous cell carcinoma

4. Clinical stages T3-4N0M0 or TxN+M0 or TxNxM1 (Only for supraclavicular lymph nodes) based on the 8th UICC-TNM classification

5. 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

Exclusion Criteria

1. Esophageal perforation or hematemesis

2. 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).

3. Previously received or receiving PD-1 antibody therapy or other immunotherapy against PD-1/PD-L1.

4. Allergic to any of the ingredients in PD-1 inhibitors for injection.

5. 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.

6. 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.

7. 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.

8. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TDLN-sparing RT and PD-1 inhibitor maintenance therapy	PD-1 inhibitor	TDLN-sparing radiotherapy 50.4Gy/28Fx. PD-1 inhibitors will be administered intravenously, a fixed dose of 200 mg, once every 3 weeks for 1 year followed by radiotherapy.
TDLN-sparing RT and PD-1 inhibitor maintenance therapy	TDLN-sparing radiotherapy	TDLN-sparing radiotherapy 50.4Gy/28Fx. PD-1 inhibitors will be administered intravenously, a fixed dose of 200 mg, once every 3 weeks for 1 year followed by radiotherapy.
TDLN-sparing RT and surveillance	TDLN-sparing radiotherapy	TDLN-sparing radiotherapy 50.4Gy/28Fx.
Unlimited RT and PD-1 inhibitor maintenance therapy	PD-1 inhibitor	Unlimited radiotherapy 50.4Gy/28Fx. PD-1 inhibitors will be administered intravenously, a fixed dose of 200 mg, once every 3 weeks for 1 year followed by radiotherapy.
Unlimited RT and surveillance	Unlimited radiotherapy	Unlimited radiotherapy 50.4Gy/28Fx.

Primary Outcome Measures

Name	Time	Method
PFS	2 years	PFS for all patients with PD-1 inhibitor maintenance therapy vs all patients with surveillance

Secondary Outcome Measures

Name	Time	Method
OS	2 years
Adverse events	up to 2 years

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, China