Current partner codePEPTIDESDE
NCT06401447·Not applicable·INTERVENTIONAL

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

Status

Active, not recruiting

Phase

Not applicable

Enrollment

50

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Full 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.

Interventions

Treatment arms and agents.

RADIATION

Radiotherapy

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

Timeline

From registration to results.

  1. First posted

    May 6, 2024

  2. Study start

    Dec 21, 2023

  3. Primary completion

    Jul 10, 2026

  4. Study completion

    Jul 10, 2027

  5. Results posted

    Not reported

  6. Registry updated

    Apr 24, 2026

Outcomes

What the study measures.

Primary outcomes

Progression Free Survival

Time frame · 1 year

From firt treatment to any disease progression or death

Secondary outcomes

clinical complete response

Time frame · 1 month after radiotherapy

disappear of tumor in CT and esophagography

Overall survival

Time frame · 1 year

From firt treatment to any death

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
80 Years
Sex
ALL
Healthy volunteers
No

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;

Study locations

1 registered sites.

China. Showing up to 24 locations stored in the fast local snapshot.

Fudan University Shanghai Cancer Center

Shanghai, China

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Thymosin Alpha-1.

Related PeptideStat pages

Put the record in context.

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