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Clinical trial No longer in our active list Interventional Ages 18 to 80

Combining chemotherapy and immunotherapy for advanced esophageal cancer

Official title: 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)

Run by Fudan University · NCT06401447 · Data updated 2026-05-14

This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.

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.

More Esophageal Squamous Cell Carcinoma trials

Quick facts

Study typeInterventional
Ages18 Years to 80 Years
SexAll
Enrollment50 (estimated)
SponsorFudan University
Academic / other
Drugs / interventionsSintilimab, chemotherapy, immunotherapy
Locations1 site (Shanghai)
Trial IDNCT06401447 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

Show full inclusion / exclusion 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 it's running

  • Fudan University Shanghai Cancer Center
    Shanghai, China     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.