Esophageal Squamous Cell CarcinomaPhase 2INS-ESCC-CTNCT07519486
Intensive Nutritional Support in Conversion Therapy for Locally Advanced Unresectable ESCC
A Phase 2 study testing PD-1 Inhibitor plus Chemotherapy, Oral Enteral Nutritional Preparation and Esophagectomy with lymph node dissection in people with Esophageal Squamous Cell Carcinoma and Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma, run by Sichuan University at 1 site in China.
Trial summary
Malnutrition is highly prevalent in patients with upper gastrointestinal tumors, which may negatively impact treatment tolerance and anti-tumor immune responses. This study aims to evaluate the efficacy and safety of intensive enteral nutritional support in patients with locally advanced unresectable esophageal… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma, Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma
- What is being tested?
- PD-1 Inhibitor plus Chemotherapy, Oral Enteral Nutritional Preparation and Esophagectomy with lymph node dissection
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteChina
- Study dates
- Apr 2026to Mar 2028
- Phase
- Phase 2
- 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
- Pathologically confirmed Esophageal Squamous Cell Carcinoma (ESCC). Aged 18-80 years, regardless of gender. ECOG Performance Status (PS) 0-2, and weight loss < 10% within the past 6 months.
- Confirmed locally advanced unresectable ESCC according to NCCN Guidelines (Version 2026.1).
- Planned to receive surgery after completion of conversion therapy, with no surgical contraindications.
- Treatment-naive: No prior anti-tumor therapy for ESCC, including radiotherapy, chemotherapy, or surgery.
- Presence of measurable lesion(s) according to RECIST 1.1. Expected survival ≥ 3 months. Able to swallow and tolerate oral medications. Adequate organ function (blood counts, biochemistry, and coagulation parameters meeting protocol requirements).
- Women of childbearing age and men must agree to use effective contraception during the study and for 6 months after completion.
- Voluntary participation with signed informed consent and good compliance.
Who cannot join
- Presence of esophageal-mediastinal fistula and/or tracheoesophageal fistula, or tumor invasion of major vessels with risk of fatal hemorrhage.
- History of other malignant tumors within the past 5 years. Current or prior use of immunosuppressants or systemic steroids (>10 mg/day prednisone equivalent) within 2 weeks prior to first dose.
- Active autoimmune disease or history of autoimmune disease requiring systemic treatment.
- Known immunodeficiency history, including HIV infection, organ transplant, or bone marrow transplant.
- Uncontrolled concurrent diseases (e.g., uncontrolled hypertension, unstable angina, recent myocardial infarction, or severe infections).
- Active tuberculosis (TB) or history of TB without standardized treatment. Active Hepatitis B (HBV) or Hepatitis C (HCV) infection. Complete inability to take oral enteral nutrition due to esophageal stenosis. History or current presence of interstitial pneumonia or interstitial lung disease.
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
- Significant gastrointestinal disorders with severe diarrhea (CTCAE > Grade 2). Pregnant or lactating women. Participation in other clinical trials within 30 days prior to enrollment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Zhenyu Ding, MD, PhD, +86-189-8060-1957, dingzhenyu@scu.edu.cn
About this study
Official title: A Prospective Randomized Controlled Clinical Trial of Intensive Nutritional Support in Conversion Therapy for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma
Malnutrition is highly prevalent in patients with upper gastrointestinal tumors, which may negatively impact treatment tolerance and anti-tumor immune responses. This study aims to evaluate the efficacy and safety of intensive enteral nutritional support in patients with locally advanced unresectable esophageal squamous cell carcinoma (ESCC) undergoing conversion therapy. Participants receiving PD-1 inhibitors combined with chemotherapy will be randomly assigned to either intensive nutritional support or standard care. The primary goal is to determine if intensive nutritional support can improve the pathological complete response (pCR) rate after subsequent surgery.
- Conditions
- Esophageal Squamous Cell Carcinoma, Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma
- Being tested
- PD-1 Inhibitor plus Chemotherapy, Oral Enteral Nutritional Preparation, Esophagectomy with lymph node dissection
- Keywords
- Esophageal Neoplasms, Nutritional Support, Neoadjuvant Therapy
- Medical subject headings
- Esophageal Squamous Cell Carcinoma, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-1 Inhibitor plus ChemotherapyDrug
PD-1 inhibitor combined with chemotherapy (Paclitaxel or Albumin-bound paclitaxel plus Cisplatin or Carboplatin), administered once every 3 weeks for 2 cycles.
Oral Enteral Nutritional PreparationDietary supplement
Oral enteral nutritional preparation taken twice daily for 2 cycles (each cycle is 3 weeks).
Esophagectomy with lymph node dissectionProcedure or surgery
Surgical resection of the esophagus and lymph node dissection, planned 4-6 weeks after the completion of conversion therapy.
| Study group | Role | What they receive |
|---|---|---|
| Intensive Nutritional Support Group | Experimental | Patients in this group receive intensive oral enteral nutritional support in addition to the standard conversion therapy (PD-1 inhibitor plus chemotherapy). Receives: Drug: PD-1 Inhibitor plus Chemotherapy; Dietary Supplement: Oral Enteral Nutritional Preparation; Procedure: Esophagectomy with lymph node dissection |
| Standard Nutritional Support Group | Active comparator | Patients in this group receive routine nutritional guidance/support in addition to the standard conversion therapy (PD-1 inhibitor plus chemotherapy) Receives: Drug: PD-1 Inhibitor plus Chemotherapy; Procedure: Esophagectomy with lymph node dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response (pCR) Rate
Defined as the absence of residual viable tumor cells in the primary tumor bed and all sampled lymph nodes (ypT0N0) according to the Mandard regression criteria, as evaluated by a blinded Independent Review Committee (BIRC).
Measured: At the time of surgery (approximately 4-6 weeks after the completion of conversion therapy).
Secondary outcomes (3)
Event-Free Survival (EFS)
The time from randomization to the date of first documentation of disease progression, recurrence after surgery, or death from any cause.
Measured: From randomization up to 2 years.
Major Pathological Response (MPR) Rate
Defined as ≤ 10% residual viable tumor cells in the primary tumor bed
Measured: At the time of surgery (approximately 4-6 weeks after conversion therapy).
Objective Response Rate (ORR)
The percentage of participants with a complete response (CR) or partial response (PR) as per RECIST v1.1 before surgery.
Measured: Approximately 2 months (after completion of 2 cycles of conversion therapy).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionMar 2028 (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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhen-Yu Ding, West China Hospital
- Investigators
- Zhenyu Ding, PhD, Study chair, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07519486
- Sponsor's protocol ID
- 2026-191
- Acronym
- INS-ESCC-CT
- Status last verified
- Apr 2026
- First submitted
- 2 Apr 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The individual participant data (IPD) that underlie the results reported in the primary publication, after de-identification (text, tables, figures, and appendices), will be shared with researchers to support the results.
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Clinical Trial of Intensive Nutritional Support in Conversion Therapy for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07519486
- Acronym / sponsor ID
- INS-ESCC-CT / 2026-191
- Conditions
- Esophageal Squamous Cell Carcinoma, Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma
- Keywords
- Esophageal Neoplasms, Nutritional Support, Neoadjuvant Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- Sichuan UniversityUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 9 Apr 2026 (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.
Malnutrition is highly prevalent in patients with upper gastrointestinal tumors, which may negatively impact treatment tolerance and anti-tumor immune responses. This study aims to evaluate the efficacy and safety of intensive enteral nutritional support in patients with locally advanced unresectable esophageal squamous cell carcinoma (ESCC) undergoing conversion therapy. Participants receiving PD-1 inhibitors combined with chemotherapy will be randomly assigned to either intensive nutritional support or standard care. The primary goal is to determine if intensive nutritional support can improve the pathological complete response (pCR) rate after subsequent surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive Nutritional Support Group | Experimental | Drug: PD-1 Inhibitor plus Chemotherapy, Dietary Supplement: Oral Enteral Nutritional Preparation, Procedure: Esophagectomy with lymph node dissectionPatients in this group receive intensive oral enteral nutritional support in addition to the standard conversion therapy (PD-1 inhibitor plus chemotherapy). |
| Standard Nutritional Support Group | Active comparator | Drug: PD-1 Inhibitor plus Chemotherapy, Procedure: Esophagectomy with lymph node dissectionPatients in this group receive routine nutritional guidance/support in addition to the standard conversion therapy (PD-1 inhibitor plus chemotherapy) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Pathologically confirmed Esophageal Squamous Cell Carcinoma (ESCC). Aged 18-80 years, regardless of gender. ECOG Performance Status (PS) 0-2, and weight loss < 10% within the past 6 months.
- Confirmed locally advanced unresectable ESCC according to NCCN Guidelines (Version 2026.1).
- Planned to receive surgery after completion of conversion therapy, with no surgical contraindications.
- Treatment-naive: No prior anti-tumor therapy for ESCC, including radiotherapy, chemotherapy, or surgery.
- Presence of measurable lesion(s) according to RECIST 1.1. Expected survival ≥ 3 months. Able to swallow and tolerate oral medications. Adequate organ function (blood counts, biochemistry, and coagulation parameters meeting protocol requirements).
Key exclusion criteria (8 listed)
- Presence of esophageal-mediastinal fistula and/or tracheoesophageal fistula, or tumor invasion of major vessels with risk of fatal hemorrhage.
- History of other malignant tumors within the past 5 years. Current or prior use of immunosuppressants or systemic steroids (>10 mg/day prednisone equivalent) within 2 weeks prior to first dose.
- Active autoimmune disease or history of autoimmune disease requiring systemic treatment.
- Known immunodeficiency history, including HIV infection, organ transplant, or bone marrow transplant.
- Uncontrolled concurrent diseases (e.g., uncontrolled hypertension, unstable angina, recent myocardial infarction, or severe infections).
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 |
|---|---|---|
| PD-1 Inhibitor plus ChemotherapyPD-1 inhibitor combined with chemotherapy (Paclitaxel or Albumin-bound paclitaxel plus Cisplatin or Carboplatin), administered once every 3 weeks for 2 cycles. | Drug | Intensive Nutritional Support Group, Standard Nutritional Support Group |
| Oral Enteral Nutritional PreparationOral enteral nutritional preparation taken twice daily for 2 cycles (each cycle is 3 weeks). | Dietary supplement | Intensive Nutritional Support Group |
| Esophagectomy with lymph node dissectionSurgical resection of the esophagus and lymph node dissection, planned 4-6 weeks after the completion of conversion therapy. | Procedure or surgery | Intensive Nutritional Support Group, Standard Nutritional Support Group |
Primary outcome
Pathological Complete Response (pCR) Rate
Time frame: At the time of surgery (approximately 4-6 weeks after the completion of conversion therapy).
Defined as the absence of residual viable tumor cells in the primary tumor bed and all sampled lymph nodes (ypT0N0) according to the Mandard regression criteria, as evaluated by a blinded Independent Review Committee (BIRC).
3 secondary outcomes
Event-Free Survival (EFS)
Time frame: From randomization up to 2 years.
Major Pathological Response (MPR) Rate
Time frame: At the time of surgery (approximately 4-6 weeks after conversion therapy).
Objective Response Rate (ORR)
Time frame: Approximately 2 months (after completion of 2 cycles of conversion therapy).
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 15 Apr 2026.
- Individual participant dataSharing planned: Yes. The individual participant data (IPD) that underlie the results reported in the primary publication, after de-identification (text, tables, figures, and appendices), will be shared with researchers to support the results.
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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.
Zhenyu Ding, PhD study chair
West China Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PD-1 Inhibitor plus Chemotherapy, Oral Enteral Nutritional Preparation and Esophagectomy with lymph node dissection in people with Esophageal Squamous Cell Carcinoma and Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma, run by Sichuan 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 8 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: looking for participants now, as of the sponsor's last update on 15 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Zhenyu Ding, PhD (+86-189-8060-1957, dingzhenyu@scu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Response (pCR) Rate (time frame: At the time of surgery (approximately 4-6 weeks after the completion of conversion therapy).). 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 15 Apr 2026.