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Esophageal NeoplasmsPhase 3POINTNCT04513418

Effects of Preoperative Enteral Immunonutrition for Esophageal Cancer Patients Given Neoadjuvant Chemoradiotherapy

A Phase 3 study testing Preoperative immunonutrition in people with Esophageal Neoplasms, run by Hecheng Li M.D., Ph.D at 6 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This randomized controlled trial will evaluate the effects of preoperative enteral immunonutrition in esophageal cancer patients undergoing neoadjuvant therapy. The purpose of this study is to determine whether preoperative immune-modulating diet before surgery can improve the rate of complications and other… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Esophageal Neoplasms
What is being tested?
Preoperative immunonutrition
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
244 participants
Where
6 sitesChina
Study dates
10 Nov 2020to 31 Dec 2028
Phase
Phase 3
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed esophageal cancer
  • Staging as cT2N0M0 with high-risk lesions (lymphovascular invasion, ≥3cm, poorly differentiated) / cT1b-2N+M0 / cT3-4aN0-3M0 with the need of neoadjuvant therapy before radical esophagectomy
  • Tolerance with oral intake (at least fluid diet)
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤2
  • Body Mass Index (BMI) ≥ 18.5 kg/m2 before recruitment
  • Patient's approval and written informed consent

Who cannot join

  • Expected survival time less than 6 months
  • Complete dysphagia
  • Pregnant or breast-feeding women
  • Unable to obey the interventions because of any reasons
  • Serious co-morbidities (cardiac, pulmonary, liver, kidney, brain, hematologic, endocrine and other diseases) in patients who cannot tolerate neoadjuvant therapy and/or surgery
  • History of previous thoracic or abdominal surgery
  • History of other malignant tumor (previous or current)
  • Patients with primary small cell carcinoma of the esophagus

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

China6 sites

  • Cancer Hospital of University of Chinese Academy of Sciences, Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

  • Ningbo Medical Center Lihuili Hospital

    Ningbo, Zhejiang, 315048

  • Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200011

  • Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200025

  • Shanghai Chest Hospital Affiliated to Shanghai Jiao Tong University

    Shanghai, Shanghai Municipality, 200030

  • Zhongshan Hospital Affiliated to Fudan University

    Shanghai, Shanghai Municipality, 200032

Other trials in China

About this study

This randomized controlled trial will evaluate the effects of preoperative enteral immunonutrition in esophageal cancer patients undergoing neoadjuvant therapy. The purpose of this study is to determine whether preoperative immune-modulating diet before surgery can improve the rate of complications and other perioperative outcomes.

Read the detailed description

Esophageal cancer ranks the fourth in mortality and the sixth in incidence among cancers in China according to the latest report of cancer epidemiology. Although the development of neoadjuvant therapy and radical esophagectomy have improved the prognosis of esophageal cancer patients, dysphagia and digestive tract reconstruction can cause malnutrition and infection-related complications. Postoperative enteral and parenteral nutrition have proved to be effective in improving outcomes after esophagectomy. However, whether to provide a preoperative nutritional support for patients with resectable esophageal cancer remains controversial.

This prospective randomized controlled trial will evaluate the effects of preoperative enteral immunonutrition in esophageal cancer patients undergoing neoadjuvant therapy. The purpose of this study is to determine whether preoperative immune-modulating diet before surgery can improve the rate of complications and other perioperative outcomes.

The sample size is estimated with the hypothesis that preoperative immunonutrition during the neoadjuvant therapy can reduce postoperative nutrition and immune-related complications after esophagectomy. According to the previously published articles, the required sample size of interventional and control arm (ratio=2:1) was calculated as 137 cases and 69 cases to detect the reduction in related complications from 50% to 30% based on a bilateral significance level (α) of 0.05 and a power of test (1-β) of 0.80. Considering an estimated drop rate of 15%, the minimum sample size of this study is 244 patients, 162 cases in the interventional group and 82 in the control group. After signing the informed consent, every eligible participant will be randomized into either group based on a computer-generated random number. Blinding will not be applied to patients and surgeons due to the difficulty in clinical practice but outcomes assessor will be masked.

Being tested
Preoperative immunonutrition
Keywords
Esophageal Neoplasms, Neoadjuvant Therapy, Enteral Nutrition, Nutrition 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.

  • Preoperative immunonutritionDietary supplement

    Preoperative immunonutrition includes an omega-3 fatty-acid enriched enteral nutritional emulsion given by oral intake, nasogastric feeding tube or jejunostomy 600ml per day, lasting for the whole period of neoadjuvant chemoradiation. Meanwhile, oral intake is encouraged to reach 25-30kcal/kg through regular food.

Study groups in NCT04513418
Study groupRoleWhat they receive
Interventional groupExperimentalPatients receive omega-3 fatty-acid enriched enteral nutritional emulsion during the neoadjuvant chemoradiotherapy. Patients are meanwhile encouraged to intake 25-30kcal/kg through regular food.
Receives: Dietary Supplement: Preoperative immunonutrition
Control groupNo interventionPatients are encouraged to intake 25-30kcal/kg through regular food without supplemental nutritional support before esophagectomy.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of postoperative nutrition and immune-related complications

    Rate of gastrointestinal complications (anastomotic leakage, gastrointestinal dysfunction), metabolic complications (electrolyte disturbances, liver or renal dysfunction) and infectious complications(wound infection, catheter-related infection, pneumonia, sepsis, or other infections requiring antibiotics).

    Measured: Up to 30 days after surgery

Secondary outcomes (14)

  1. Completion rate of neoadjuvant therapy and esophagectomy

    Measured: 2-3 months before surgery

  2. Adverse events during neoadjuvant chemoradiotherapy

    Measured: 2-3 months before surgery

  3. Pathological complete response rate (pCR)

    Measured: 2-3 months before surgery

  4. Blood loss

    Measured: At operation day

  5. Duration of surgery

    Measured: At operation day

  6. Rate of surgery-related complications

    Conversion to open surgery, recurrent nerve injury, cardiac and cerebrovascular accident

    Measured: At operation day

  7. Length of hospital stay

    Measured: Postoperative in-hospital stay

  8. Hospitalization costs

    Measured: Postoperative in-hospital stay

  9. 30-day and 90-day mortality

    Measured: Up to 90 days after surgery

  10. Weight loss

    Measured: From neoadjuvant chemoradiotherapy to 6 months after surgery

  11. Change in PG-SGA score after surgery

    Measured: From neoadjuvant chemoradiotherapy to 6 months after surgery

  12. Change in biochemical indicators after surgery

    WBC, hemoglobin, albumin, CRP, TNF-α, interleukins, IgA, IgG, IgM, fasting blood-glucose

    Measured: From neoadjuvant chemoradiotherapy to 6 months after surgery

  13. Score of EORTC QLQ-C30 and OES-18 scale

    Quality of life

    Measured: 1-year, 3-year, and 5-year after surgery

  14. Long-term survival

    Overall survival (OS) and progression-free survival (PFS)

    Measured: 1-year, 3-year, and 5-year after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2020
  2. Study start10 Nov 2020
  3. Primary completion16 Mar 2025
  4. Study completion31 Dec 2028 (estimated)

Resources

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 3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
244 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04513418
Sponsor's protocol ID
RTS-011
Acronym
POINT
Status last verified
May 2026
First submitted
7 Aug 2020
Last updated
2 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cheng Y, Cao Y, Zhao S, Jin Q, Li J, Li C, Zhang Y, Shen W, He J, Wang M, Ji G, Li Z, He Y, Chen Q, Wei W, Tan L, Wang H, Shi Y, Li H. Updated protocol of the POINT trial: a multicenter randomized controlled trial investigating effects of preoperative enteral immunonutrition for esophageal cancer patients treated with neoadjuvant chemoradiotherapy. Trials. 2025 Oct 10;26(1):401. doi: 10.1186/s13063-025-09117-w.

    PubMed 41074192

  • Cao Y, Han D, Yang S, Shi Y, Zhao S, Jin Q, Li J, Li C, Zhang Y, Shen W, He J, Wang M, Ji G, Li Z, He Y, Chen Q, Wei W, Chen C, Gong X, Wang J, Tan L, Wang H, Li H. Effects of pre-operative enteral immunonutrition for esophageal cancer patients treated with neoadjuvant chemoradiotherapy: protocol for a multicenter randomized controlled trial (point trial, pre-operative immunonutrition therapy). BMC Cancer. 2022 Jun 13;22(1):650. doi: 10.1186/s12885-022-09721-y.

    PubMed 35698100

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Preoperative immunonutrition in people with Esophageal Neoplasms, run by Hecheng Li M.D., Ph.D at 6 sites 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 6 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: under way, not looking for participants, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

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?

Rate of postoperative nutrition and immune-related complications (time frame: Up to 30 days after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04513418, which also lists 2 linked publications.

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 2 Jun 2026.

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