Esophageal CancerINSECNTNCT07067359
The Intensive Nutritional Support in Esophageal Cancer Undergoing Neoadjuvant Therapy
A study testing Enteral Nutrition in people with Esophageal Cancer, run by Sichuan University.
Trial summary
Patients with esophageal cancer undergoing neoadjuvant therapy were selected as research subjects for nutritional risk screening and malnutrition assessment. Patients identified with nutritional risk were randomized into the standard nutrition therapy group (SNT) and the intensive nutrition therapy group (INT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Enteral Nutrition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2025to 30 Dec 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Esophageal cancer；
- Patients were staged as cT1b-cT2N+M0 or cT3-cT4a, any N, M0. Based on the location of the tumor and clinical staging, they were defined as locally advanced resectable esophageal cancer；
- Patients planned for neoadjuvant therapy, with radical surgical resection intended after neoadjuvant treatment；
- Normal gastrointestinal function；
- PG-SGA score >3;
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤2分.
Who cannot join
- Other tumors, including pancreatic cancer, liver cancer and other solid digestive tract tumors, colon cancer, rectal cancer and other tubular lower digestive tract tumors;
- Have serious heart, lung and brain diseases;
- Patients with unstable vital signs and multiple organ failure;
- The patient has poor cognitive ability and is unable to answer questions or fill out questionnaires;
- Eastern Cooperative Oncology Group score >2;
- The investigator believes that the subjects have a history of other serious systemic diseases or are not suitable for participating in this clinical study for other reasons
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Intensive Nutrition Intervention in Esophagogastric Cancer Patients With Neoadjuvant Therapy: A Randomized Clinical Trial
Patients with esophageal cancer undergoing neoadjuvant therapy were selected as research subjects for nutritional risk screening and malnutrition assessment. Patients identified with nutritional risk were randomized into the standard nutrition therapy group (SNT) and the intensive nutrition therapy group (INT). The surgical rate was evaluated in both groups of patients, and the effects of nutritional support therapy on nutritional status and quality of life were investigated.
Read the detailed description
Esophageal cancer is one of the most common malignant tumors in China, with high incidence and mortality rates. Due to its anatomical location and pathological characteristics, patients with esophageal cancer often experience symptoms such as dysphagia and reduced appetite at an early stage of the disease, leading to inadequate nutritional intake and subsequent malnutrition. Malnutrition not only weakens the immune function of patients but also reduces their tolerance to surgery, radiotherapy, and chemotherapy. It may also prolong hospital stays, increase the incidence of complications, and ultimately affect patient prognosis and quality of life. Therefore, conducting nutritional risk screening and malnutrition assessment for patients with esophageal cancer, and providing targeted nutritional support therapy based on these assessments, is of significant importance for improving clinical outcomes.
This study selected patients with esophageal cancer undergoing neoadjuvant therapy as the research subjects. All enrolled patients underwent comprehensive nutritional risk screening and malnutrition assessment prior to enrollment. After completing the nutritional risk screening and assessment, patients identified with nutritional risk were randomly divided into two groups: the Standard Nutrition Therapy group (SNT) and the Intensive Nutrition Therapy group (INT). Patients in the Standard Nutrition Therapy group (SNT) received a conventional nutritional support regimen during hospitalization, which included dietary guidance and necessary nutritional supplements. In contrast, patients in the Intensive Nutrition Therapy group (INT) not only received the standard regimen but also continued to receive ongoing nutritional counseling and monitoring after discharge, ensuring sustained nutritional support for the patients.
The primary research content of this study includes the surgical resection rate. By comparing the surgical rates between the two groups of patients, the impact of different nutritional support regimens on patients' surgical opportunities was assessed. Additionally, the effectiveness of nutritional support therapy in improving patients' nutritional status was evaluated by regularly monitoring changes in nutritional indicators such as body weight, body mass index (BMI), and serum albumin levels.
This study aims to provide high-quality clinical evidence for the nutritional support treatment of patients with esophageal cancer through a randomized controlled trial. We anticipate that patients in the intensive nutrition therapy group will outperform those in the standard nutrition therapy group in terms of surgical rates and improvement in nutritional status. Through this study, we hope to further optimize the nutritional management strategies for patients with esophageal cancer, provide more targeted nutritional support regimens for clinicians, and thereby improve patient prognosis.
- Conditions
- Esophageal Cancer
- Being tested
- Enteral Nutrition
- Keywords
- Esophageal Cancer, nutrition, Neoadjuvant therapy
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enteral NutritionDietary supplement
Also called Nutritional supplements, Dietary guidance
This study selected patients with esophageal cancer undergoing neoadjuvant therapy as the research subjects. All enrolled patients underwent comprehensive nutritional risk screening and malnutrition assessment prior to enrollment. After the completion of nutritional risk screening and assessment, patients identified with nutritional risk were randomly assigned to two groups: the Standard Nutrition Therapy group (SNT) and the Intensive Nutrition Therapy group (INT). Patients in the SNT group received a conventional nutritional support regimen during hospitalization, which included dietary guidance and necessary nutritional supplements. In addition to the standard regimen, patients in the INT group continued to receive ongoing nutritional counseling and nutritional supplement support after discharge to ensure sustained nutritional support.
| Study group | Role | What they receive |
|---|---|---|
| Intensive Nutrition therapy (INT) | Experimental | Esophageal cancer patients with nutritional risk undergoing neoadjuvant therapy received dietary guidance and necessary nutritional supplements during hospitalization. In addition to this, they continued to receive ongoing nutritional counseling and monitoring after discharge to ensure sustained nutritional support. Receives: Dietary Supplement: Enteral Nutrition |
| Standard Nutrition Therapy (SNT) | Active comparator | Esophageal cancer patients with nutritional risk undergoing neoadjuvant therapy received a conventional nutritional support regimen during hospitalization, including dietary guidance and necessary nutritional supplements. Receives: Dietary Supplement: Enteral Nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical resection rate
The proportion of esophageal cancer patients who undergo radical surgical resection after neoadjuvant therapy.
Measured: Through study completion, an average of 1 year
Secondary outcomes (6)
Objective response rate (ORR)
The Objective Response Rate (ORR) refers to the proportion of patients whose tumor lesions completely disappear (Complete Response, CR) or partially shrink (Partial Response, PR) during neoadjuvant therapy.
Measured: From the start of the first neoadjuvant treatment to four weeks after the first tumor assessment.
The rate of pathological complete response (pCR)
Pathological Complete Response (pCR) refers to the absence of any residual cancer cells in the tumor tissue resected after neoadjuvant therapy.
Measured: Through study completion, an average of 1 year
Event free survival (EFS)
Event-Free Survival (EFS) refers to the time from the start of treatment to the first occurrence of disease progression, recurrence, death, or other predefined adverse events.
Measured: From the start of the first neoadjuvant treatment, the observation period is up to 2 years.
Overall survival (OS)
Overall Survival (OS) refers to the time from the start of treatment to the patient's death from any cause.
Measured: From the start of the first neoadjuvant treatment, the observation period is up to 2 years.
Nutrition status
The nutritional status of patients was assessed using Patient-Generated Subjective Global Assessment (PG-SGA) before neoadjuvant therapy and before surgery. PG-SGA is a multidimensional tool for assessing patients' nutritional status and is widely used in oncology and other chronic catabolic diseases. This tool combines the patient's self-assessment with the assessment by healthcare professionals and can comprehensively reflect the patient's nutritional state and nutritional risk. The higher the score, the worse the patient's nutritional status. 0-1 point: Good nutritional status. 2-8 points: Suspected or moderate malnutrition. ≥9 points: Severe malnutrition.
Measured: Perioperative
Quality of life (QOL)
Quality of life was assessed before neoadjuvant therapy and before surgery. Quality of life was assessed using the Uropean Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) scale. The EORTC QLQ-C30 scale is a standardized and validated tool for assessing health-related quality of life (HRQoL) in cancer patients, developed by the European Organization for Research and Treatment of Cancer (EORTC). Scoring range: 0-100 points. Higher scores indicate better functional status and higher quality of life.
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start15 Jul 2025 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Sichuan 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental: Intensive Nutrition therapy (INT) Esophageal cancer patients with nutritional risk undergoing neoadjuvant therapy received dietary guidance and necessary nutritional supplements during hospitalization. In addition to this, they continued to receive ongoing nutritional counseling and monitoring after discharge to ensure sustained nutritional support. Active Comparator: Standard Nutrition Therapy (SNT) Esophageal cancer patients with nutritional risk undergoing neoadjuvant therapy received a conventional nutritional support regimen during hospitalization, including dietary guidance and necessary nutritional supplements.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhen-Yu Ding, Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07067359
- Sponsor's protocol ID
- HX2023382
- Acronym
- INSECNT
- Status last verified
- Jul 2025
- First submitted
- 23 Jan 2025
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intensive Nutrition Intervention in Esophagogastric Cancer Patients With Neoadjuvant Therapy: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07067359
- Acronym / sponsor ID
- INSECNT / HX2023382
- Conditions
- Esophageal Cancer
- Keywords
- Esophageal Cancer, nutrition, Neoadjuvant therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sichuan UniversityUniversity, hospital or other
- Study start
- 15 Jul 2025 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 16 Jul 2025 (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.
Patients with esophageal cancer undergoing neoadjuvant therapy were selected as research subjects for nutritional risk screening and malnutrition assessment. Patients identified with nutritional risk were randomized into the standard nutrition therapy group (SNT) and the intensive nutrition therapy group (INT). The surgical rate was evaluated in both groups of patients, and the effects of nutritional support therapy on nutritional status and quality of life were investigated.
Detailed description
Esophageal cancer is one of the most common malignant tumors in China, with high incidence and mortality rates. Due to its anatomical location and pathological characteristics, patients with esophageal cancer often experience symptoms such as dysphagia and reduced appetite at an early stage of the disease, leading to inadequate nutritional intake and subsequent malnutrition. Malnutrition not only weakens the immune function of patients but also reduces their tolerance to surgery, radiotherapy, and chemotherapy. It may also prolong hospital stays, increase the incidence of complications, and ultimately affect patient prognosis and quality of life. Therefore, conducting nutritional risk screening and malnutrition assessment for patients with esophageal cancer, and providing targeted nutritional support therapy based on these assessments, is of significant importance for improving clinical outcomes.
This study selected patients with esophageal cancer undergoing neoadjuvant therapy as the research subjects. All enrolled patients underwent comprehensive nutritional risk screening and malnutrition assessment prior to enrollment. After completing the nutritional risk screening and assessment, patients identified with nutritional risk were randomly divided into two groups: the Standard Nutrition Therapy group (SNT) and the Intensive Nutrition Therapy group (INT). Patients in the Standard Nutrition Therapy group (SNT) received a conventional nutritional support regimen during hospitalization, which included dietary guidance and necessary nutritional supplements. In contrast, patients in the Intensive Nutrition Therapy group (INT) not only received the standard regimen but also continued to receive ongoing nutritional counseling and monitoring after discharge, ensuring sustained nutritional support for the patients.
The primary research content of this study includes the surgical resection rate. By comparing the surgical rates between the two groups of patients, the impact of different nutritional support regimens on patients' surgical opportunities was assessed. Additionally, the effectiveness of nutritional support therapy in improving patients' nutritional status was evaluated by regularly monitoring changes in nutritional indicators such as body weight, body mass index (BMI), and serum albumin levels.
This study aims to provide high-quality clinical evidence for the nutritional support treatment of patients with esophageal cancer through a randomized controlled trial. We anticipate that patients in the intensive nutrition therapy group will outperform those in the standard nutrition therapy group in terms of surgical rates and improvement in nutritional status. Through this study, we hope to further optimize the nutritional management strategies for patients with esophageal cancer, provide more targeted nutritional support regimens for clinicians, and thereby improve patient prognosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Experimental: Intensive Nutrition therapy (INT) Esophageal cancer patients with nutritional risk undergoing neoadjuvant therapy received dietary guidance and necessary nutritional supplements during hospitalization. In addition to this, they continued to receive ongoing nutritional counseling and monitoring after discharge to ensure sustained nutritional support. Active Comparator: Standard Nutrition Therapy (SNT) Esophageal cancer patients with nutritional risk undergoing neoadjuvant therapy received a conventional nutritional support regimen during hospitalization, including dietary guidance and necessary nutritional supplements.
| Arm | Type | Receives |
|---|---|---|
| Intensive Nutrition therapy (INT) | Experimental | Dietary Supplement: Enteral NutritionEsophageal cancer patients with nutritional risk undergoing neoadjuvant therapy received dietary guidance and necessary nutritional supplements during hospitalization. In addition to this, they continued to receive ongoing nutritional counseling and monitoring after discharge to ensure sustained nutritional support. |
| Standard Nutrition Therapy (SNT) | Active comparator | Dietary Supplement: Enteral NutritionEsophageal cancer patients with nutritional risk undergoing neoadjuvant therapy received a conventional nutritional support regimen during hospitalization, including dietary guidance and necessary nutritional supplements. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Esophageal cancer；
- Patients were staged as cT1b-cT2N+M0 or cT3-cT4a, any N, M0. Based on the location of the tumor and clinical staging, they were defined as locally advanced resectable esophageal cancer；
- Patients planned for neoadjuvant therapy, with radical surgical resection intended after neoadjuvant treatment；
- Normal gastrointestinal function；
- PG-SGA score >3;
Key exclusion criteria (6 listed)
- Other tumors, including pancreatic cancer, liver cancer and other solid digestive tract tumors, colon cancer, rectal cancer and other tubular lower digestive tract tumors;
- Have serious heart, lung and brain diseases;
- Patients with unstable vital signs and multiple organ failure;
- The patient has poor cognitive ability and is unable to answer questions or fill out questionnaires;
- Eastern Cooperative Oncology Group score >2;
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 |
|---|---|---|
| Enteral NutritionAlso: Nutritional supplements, Dietary guidanceThis study selected patients with esophageal cancer undergoing neoadjuvant therapy as the research subjects. All enrolled patients underwent comprehensive nutritional risk screening and malnutrition assessment prior to enrollment. After the completion of nutritional risk screening and assessment, patients identified with nutritional risk were randomly assigned to two groups: the Standard Nutrition Therapy group (SNT) and the Intensive Nutrition Therapy group (INT). Patients in the SNT group received a conventional nutritional support regimen during hospitalization, which included dietary guidance and necessary nutritional supplements. In addition to the standard regimen, patients in the INT group continued to receive ongoing nutritional counseling and nutritional supplement support after discharge to ensure sustained nutritional support. | Dietary supplement | Intensive Nutrition therapy (INT), Standard Nutrition Therapy (SNT) |
Primary outcome
Surgical resection rate
Time frame: Through study completion, an average of 1 year
The proportion of esophageal cancer patients who undergo radical surgical resection after neoadjuvant therapy.
6 secondary outcomes
Objective response rate (ORR)
Time frame: From the start of the first neoadjuvant treatment to four weeks after the first tumor assessment.
The rate of pathological complete response (pCR)
Time frame: Through study completion, an average of 1 year
Event free survival (EFS)
Time frame: From the start of the first neoadjuvant treatment, the observation period is up to 2 years.
Overall survival (OS)
Time frame: From the start of the first neoadjuvant treatment, the observation period is up to 2 years.
Nutrition status
Time frame: Perioperative
Quality of life (QOL)
Time frame: Perioperative
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 16 Jul 2025.
Related trials for Esophageal Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
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.
Questions about this trial
What is this clinical trial studying?
A study testing Enteral Nutrition in people with Esophageal Cancer, run by Sichuan University.
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 6 inclusion and 6 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: opening soon, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Qing Li, PhD (+8618702848178, liqing@scu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical resection rate (time frame: Through study completion, an average of 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 16 Jul 2025.