Esophageal Squamous Cell CarcinomaNCT06401447
TPF Concurrent Chemo-radiotherapy Plus Immunotherapy for Local Advanced Esophageal Squamous Cell Carcinoma
A study testing Radiotherapy in people with Esophageal Squamous Cell Carcinoma, run by Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- What is being tested?
- Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 21 Dec 2023to 10 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sign written informed consent before implementing any trial related procedures;
- Age range from 18 to 80 years old;
- Stage II-III and stage IV esophageal squamous cell carcinoma with only extraregional lymph node metastasis determined by histopathology;
- Inability to undergo surgical resection or patient refusal to undergo surgery;
- ECOG PS 0-1;
- Expected survival time>3 months;
- Sufficient organ function is required for the subject to meet laboratory indicators
Who cannot join
- After esophageal or tracheal stent implantation surgery;
- 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;
- Diagnosed as malignant diseases other than esophageal cancer within 3 years prior to initial administration (excluding those that have undergone curative treatment)
- 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;
- 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;
Trial locations and contacts
1 site in 1 country.
About this study
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)
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:
- Does immune microenvironment could be modified by medium dose of three drugs (paclitaxel, cisplatin, 5-FU), PD1 checkpoint inhibitor, probiotics, and thymosin α1？
- Does induction and consolidation of PD1 checkpoint inhibitor improve the effect of chemoradiotherapy for patients with esophageal cancer?
Read more
This is a single arm study. Participants will:
- 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.
- Take probiotics (Clostridium Butyricum) for 1 year and thymosin alpha-1 daily during radiotherapy.
Read the 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
- Being tested
- Radiotherapy
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
Simultaneously optimizing the target, dosage, and synchronized drugs for radiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | 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. Receives: Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
From firt treatment to any disease progression or death
Measured: 1 year
Secondary outcomes (2)
clinical complete response
disappear of tumor in CT and esophagography
Measured: 1 month after radiotherapy
Overall survival
From firt treatment to any death
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start21 Dec 2023
- Primary completion10 Jul 2026 (estimated)
- Study completion10 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kailiang Wu, Fudan University
- Investigators
- Kailiang Wu, Doctor, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06401447
- Sponsor's protocol ID
- 2810284-3
- Status last verified
- Apr 2026
- First submitted
- 2 May 2024
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06401447
- Acronym / sponsor ID
- 2810284-3
- Conditions
- Esophageal Squamous Cell Carcinoma
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 21 Dec 2023 (actual)
- Primary completion
- 10 Jul 2026 (estimated)
- Study completion
- 10 Jul 2027 (estimated)
- First posted
- 6 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does immune microenvironment could be modified by medium dose of three drugs (paclitaxel, cisplatin, 5-FU), PD1 checkpoint inhibitor, probiotics, and thymosin α1？
- 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:
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Radiation: Radiotherapy1. 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Sign written informed consent before implementing any trial related procedures;
- Age range from 18 to 80 years old;
- Stage II-III and stage IV esophageal squamous cell carcinoma with only extraregional lymph node metastasis determined by histopathology;
- Inability to undergo surgical resection or patient refusal to undergo surgery;
- ECOG PS 0-1;
Key exclusion criteria (5 listed)
- After esophageal or tracheal stent implantation surgery;
- 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;
- Diagnosed as malignant diseases other than esophageal cancer within 3 years prior to initial administration (excluding those that have undergone curative treatment)
- 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;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadiotherapySimultaneously optimizing the target, dosage, and synchronized drugs for radiotherapy. | Radiation | Treatment Arm |
Primary outcome
Progression Free Survival
Time frame: 1 year
From firt treatment to any disease progression or death
2 secondary outcomes
clinical complete response
Time frame: 1 month after radiotherapy
Overall survival
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kailiang Wu, Doctor principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiotherapy in people with Esophageal Squamous Cell Carcinoma, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.