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

NCT ID: NCT06401447

Last Updated: 2024-05-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2026-12-01

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. Does immune microenvironment could be modified by medium dose of three drugs (paclitaxel, cisplatin, 5-FU), PD1 checkpoint inhibitor, probiotics, and thymosin α1？

2. Does induction and consolidation of PD1 checkpoint inhibitor improve the effect of chemoradiotherapy for patients with esophageal cancer?

This is a single arm study. Participants will:

1. 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.

2. Take probiotics (Clostridium Butyricum) for 1 year and thymosin alpha-1 daily during radiotherapy.

Detailed Description

Concurrent chemoradiotherapy is the standard treatment for patients with inoperable local advanced esophageal squamous cell carcinoma. However, over half of patients will relapse. How to improve effects? We focus on tumor microenvironment transformation by three drug chemotherapy, PD1 inhibitor, probiotics, and thymosin α1，and intent to improve radiosensitivity and reduce recurrence.

Conditions

Esophageal Squamous Cell Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Arm

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.

Group Type: EXPERIMENTAL

Radiotherapy

Intervention Type: RADIATION

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

Interventions

Radiotherapy

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

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

1. Sign written informed consent before implementing any trial related procedures;

2. Age range from 18 to 80 years old;

3. Stage II-III and stage IV esophageal squamous cell carcinoma with only extraregional lymph node metastasis determined by histopathology;

4. Inability to undergo surgical resection or patient refusal to undergo surgery;

5. ECOG PS 0-1;

6. Expected survival time>3 months;

7. Sufficient organ function is required for the subject to meet laboratory indicators

Exclusion Criteria

1. After esophageal or tracheal stent implantation surgery;

2. 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;

3. Diagnosed as malignant diseases other than esophageal cancer within 3 years prior to initial administration (excluding those that have undergone curative treatment)

4. 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;

5. 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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Kailiang Wu

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kailiang Wu, Doctor

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Fudan University Shanghai Cancer Center

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Xingwen Fan, Doctor

Role: CONTACT

wenxingfan@126.com

+8613651669687

Facility Contacts

Xingwen Fan, Doctor

Role: primary

wenxingfan@126.com

+8613651669687

Other Identifiers

2810284-3

Identifier Type: -

Identifier Source: org_study_id