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Trial Title:
TPF Concurrent Chemo-radiotherapy Plus Immunotherapy for Local Advanced Esophageal Squamous Cell Carcinoma
NCT ID:
NCT06401447
Condition:
Esophageal Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Radiotherapy
Description:
Simultaneously optimizing the target, dosage, and synchronized drugs for radiotherapy.
Arm group label:
Treatment Arm
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.
Criteria for 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;
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Xingwen Fan, Doctor
Phone:
+8613651669687
Email:
wenxingfan@126.com
Start date:
December 1, 2023
Completion date:
December 1, 2026
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06401447
