Combining chemotherapy and immunotherapy for advanced esophageal cancer

Medium Dose of Three Drugs (TPF) Concurrent Chemoradiotherapy Combined With PD-1 Checkpoint Inhibitor for Locally Advanced Esophageal Squamous Cell Carcinoma --Prospective, Single Center, Single Arm, Phase II Clinical Study (FUTURE-2)

This study is testing if adding immunotherapy and other supportive treatments to standard chemotherapy can help people with advanced esophageal cancer respond better to treatment and lower their chances of the cancer coming back.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Fudan University (other)
• Drugs / interventions: Sintilimab, chemotherapy, immunotherapy
• Locations: 1 site (Shanghai)
• Trial ID: NCT06401447 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to determine if modifying the immune microenvironment can enhance the effectiveness of chemoradiotherapy in patients with locally advanced esophageal squamous cell carcinoma. Participants will undergo a regimen that includes induction chemotherapy with paclitaxel, cisplatin, and 5-FU, followed by concurrent chemoradiotherapy and consolidation immunotherapy with a PD1 checkpoint inhibitor. Additionally, patients will take probiotics and thymosin α1 to support their treatment over the course of one year. The study seeks to improve radiosensitivity and reduce the likelihood of cancer recurrence.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with stage II-III or stage IV esophageal squamous cell carcinoma who cannot undergo surgery.

Not a fit: Patients with significant tumor invasion into adjacent organs or those with other malignancies diagnosed within the last three years may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve treatment outcomes and reduce recurrence rates for patients with advanced esophageal cancer.

How similar studies have performed: While concurrent chemoradiotherapy is standard, the combination of immune microenvironment modification with this approach is novel and has not been extensively tested in prior studies.

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;

Where this trial is running

Shanghai

• Fudan University Shanghai Cancer Center — Shanghai, China (RECRUITING)

Study contacts

• Principal investigator: Kailiang Wu, Doctor — Fudan University
• Study coordinator: Xingwen Fan, Doctor

Conditions: Esophageal Squamous Cell Carcinoma