TPF Concurrent Chemo-radiotherapy Plus Immunotherapy for Local Advanced Esophageal Squamous Cell Carcinoma

NCT06401447 | Active Not Recruiting

• 1 other identifier: 2810284-3
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if immune microenvironment modification could improve the effect of chemoradiotherapy for patients with local advanced esophageal squamous cell carcinoma. The main questions it aims to answer are:

1. 1.Does immune microenvironment could be modified by medium dose of three drugs (paclitaxel, cisplatin, 5-FU), PD1 checkpoint inhibitor, probiotics, and thymosin α1？
2. 2.Does induction and consolidation of PD1 checkpoint inhibitor improve the effect of chemoradiotherapy for patients with esophageal cancer?
3. 3.Take one cycle of induction chemotherapy (paclitaxel, cisplatin, 5-FU) and immunotherapy (Sintilimab), two cycle of concurrent chemoradiotherapy, one cycle of consolidation chemo-immunotherapy, and then 1 year of immunotherapy.
4. 4.Take probiotics (Clostridium Butyricum) for 1 year and thymosin alpha-1 daily during radiotherapy.

Conditions

Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  From firt treatment to any disease progression or death

  1 year

Secondary Outcomes (2)

• clinical complete response

  1 month after radiotherapy

• Overall survival

  1 year

Study Arms (1)

Treatment Arm

EXPERIMENTAL

1. Take one cycle of induction chemo-immunotherapy, two cycle of concurrent chemoradiotherapy 3 weeks later, one cycle of consolidation chemo-immunotherapy 1 month after radiotherapy, and then 1 year of immunotherapy. 2. Radiotherapy: intensity modulated radiotherapy or volume modulated therapy. Modified involving field irradiation. PTV-C of 50.4Gy/28F, and PTV-G of 61.6Gy/28F with simultaneous integrated boost if no deep ulcers. 3. Chemotherapy: paclitaxel 60mg/m2, ivgtt; cisplatin 30mg/m2, ivgtt; 5-FU 500mg/m2, ivgtt and 500mg/m2, civ 24h; calcium folinate 200mg; q3w. 4. Immunotherapy: Sintilimab, 200mg, q3w. 5. Probiotics: Clostridium Butyricum (MIYAIRI 588), 20mg, tid, for 1 year. 6. Thymosin alpha-1: 1.6mg, qd, d1-5 during radiotherapy.

Radiation: Radiotherapy

Interventions

Radiotherapy RADIATION

Simultaneously optimizing the target, dosage, and synchronized drugs for radiotherapy.

Treatment Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sign written informed consent before implementing any trial related procedures;
• Age range from 18 to 80 years old;
• Stage II-III and stage IV esophageal squamous cell carcinoma with only extraregional lymph node metastasis determined by histopathology;
• Inability to undergo surgical resection or patient refusal to undergo surgery;
• ECOG PS 0-1;
• Expected survival time\>3 months;
• Sufficient organ function is required for the subject to meet laboratory indicators

You may not qualify if:

• After esophageal or tracheal stent implantation surgery;
• Due to the obvious invasion of tumors into adjacent organs (arteries or trachea) of the esophageal lesion, there is a higher risk of Patients at risk of bleeding or perforation, or those who have formed fistulas;
• Diagnosed as malignant diseases other than esophageal cancer within 3 years prior to initial administration (excluding those that have undergone curative treatment)
• Currently participating in intervention clinical research treatment, or having received other treatments within 4 weeks prior to initial administration Researching drugs or using research instruments for treatment;
• Previously received the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs, or targeting another stimulus or synergistic inhibition of T cell receptors (such as CTLA-4, OX-40, CD137) Medications;

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China

Location

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Kailiang Wu, Doctor

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: May 2, 2024
• First Posted: May 6, 2024
• Study Start: December 21, 2023
• Primary Completion (Estimated): July 10, 2026
• Study Completion (Estimated): July 10, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)