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Gastric Cancer (GC)NCT07444099

Early Postoperative Intervention in Gastric Cancer Patients

A study testing Early structured postoperative intervention encompassing nutrition, psychology, and exercise in people with Gastric Cancer (GC) and Postoperative Recovery, run by Qilu Hospital of Shandong University at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

This study was conducted by Qilu Hospital and five other renowned medical centers, aiming to evaluate the impact of early structured postoperative intervention on quality of life and prognosis in patients with gastric cancer after neoadjuvant therapy. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Gastric Cancer (GC), Postoperative Recovery
What is being tested?
Early structured postoperative intervention encompassing nutrition, psychology, and exercise
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
264 participants
Where
1 siteChina
Study dates
10 Feb 2026to 30 Jun 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

  • Age 18-80 years;
  • Histologically confirmed adenocarcinoma by preoperative pathology;
  • Completed preoperative neoadjuvant therapy without obvious immune-related adverse events (irAEs);
  • Patients with ycT3-4N+Mx disease deemed surgically resectable based on evaluation by gastroscopy, CT, PET-CT, and other imaging modalities;
  • Signed informed consent and voluntary participation in this study;
  • Standard ERAS (Enhanced Recovery After Surgery) management during the - perioperative period, with postoperative hospital stay ≤7 days.

Who cannot join

  • Patients with central nervous system diseases or psychiatric disorders;
  • Patients with severe diseases of other organ systems;
  • Patients with recurrent infectious diseases or severe comorbidities;
  • Patients requiring synchronous surgery for other diseases;
  • Patients undergoing emergency surgery;
  • Patients who developed any complication during hospitalization.

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

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012

Other trials in China

About this study

Official title: Early Postoperative Structured Intervention for Quality of Life and Prognosis in Gastric Cancer Patients After Neoadjuvant Therapy：: A Multicenter,Open Label Randomized Controlled Trial

This study was conducted by Qilu Hospital and five other renowned medical centers, aiming to evaluate the impact of early structured postoperative intervention on quality of life and prognosis in patients with gastric cancer after neoadjuvant therapy.

Read the detailed description

Investigators are conducting a two-arm, multicenter, interventional study at Qilu Hospital of Shandong University and five other renowned hospitals in China. A total of 264 gastric cancer patients who have completed preoperative neoadjuvant therapy will be randomly assigned to either the control group or the experimental group.For control group,patients will receive standard ERAS discharge management, including routine discharge education; outpatient follow-up visits on postoperative day 7 and postoperative day 30; and emergency contact via hospital telephone or emergency department visits for urgent situations.For experimental group,in addition to standard ERAS discharge management, patients will receive multimodal structured interventions during follow-up visits targeting nutritional status, psychological status, and exercise status. Nutritional intervention: Routine postoperative oral nutritional supplements (ONS) will be provided, and patients with metabolic diseases such as diabetes will undergo strict glycemic control. Psychological intervention: Patients with a Hospital Anxiety and Depression Scale (HADS) score ≥ 8 will receive cognitive behavioral therapy (CBT), and those with a HADS score ≥ 11 will be referred for psychological consultation. Exercise intervention: Postoperative rehabilitation training will be guided according to different postoperative periods.During the study period, the incidence of complications within 30 days postoperatively and quality of postoperative recovery were statistically analyzed, among other outcomes.

Being tested
Early structured postoperative intervention encompassing nutrition, psychology, and exercise
Keywords
gastric cancer, postoperative care, postoperative complications, recover quality
Medical subject headings
Stomach Neoplasms, Postoperative Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Early structured postoperative intervention encompassing nutrition, psychology, and exerciseCombination product

    Nutritional intervention: Routine postoperative oral nutritional supplements (ONS) will be provided, and patients with metabolic diseases such as diabetes will undergo strict glycemic control. Psychological intervention: Patients with a Hospital Anxiety and Depression Scale (HADS) score ≥ 8 will receive cognitive behavioral therapy (CBT), and those with a HADS score ≥ 11 will be referred for psychological consultation. Exercise intervention: Postoperative rehabilitation training will be guided according to different postoperative periods.

Study groups in NCT07444099
Study groupRoleWhat they receive
Patients with early structured postoperative interventionExperimentalNot described
Receives: Combination Product: Early structured postoperative intervention encompassing nutrition, psychology, and exercise
Patients without early structured postoperative interventionNo interventionNot described

What is being measured

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

  1. incidence of complications within 30 days postoperatively

    The incidence of complications within 30 days postoperatively was calculated as the number of patients who developed complications within 30 days after surgery divided by the total number of patients in that group.

    Measured: 30 days after operation

  2. Postoperative recovery quality

    Postoperative recovery quality was assessed using The 15-item Quality of Recovery Score scale, with a maximum score of 150 points and a minimum score of 0 points, where higher scores indicate better postoperative recovery quality

    Measured: Baseline (Day of Discharge) and POD 30（30 days after surgery）

Secondary outcomes (5)

  1. Readmission or emergency department visit rate within 30 days postoperatively

    The rate of Readmission or emergency department visit within 30 days postoperatively was calculated as the number of patients who was readmitted or visited emergency department within 30 days after surgery divided by the total number of patients in that group.

    Measured: 30 days after surgery

  2. Time interval between surgery and initiation of adjuvant chemotherapy

    The time interval was calculated as the number of days from postoperative day 1 to the start of adjuvant chemotherapy.

    Measured: 6 month after surgery

  3. Completion rate of postoperative chemotherapy / Adherence to adjuvant chemotherapy

    The completion rate of postoperative chemotherapy was calculated as the number of chemotherapy cycles actually completed divided by the number of chemotherapy cycles planned.

    Measured: 6 month after surgery

  4. Grading of chemotherapy-related adverse events

    It was evaluated by CTCAE version 5.0，with severity classified from Grade 1 (mild) to Grade 5 (death).

    Measured: 6 month after surgery

  5. Postoperative quality of life score

    The EORTC Quality of Life Questionnaire for Gastric Cancer (C30 + STO22) questionaire was used to evaluate quality of postoperative recovery, all scales range from 0 to 100. For global health status, higher scores indicate better outcomes; for all functioning and symptom scales in both questionnaires, higher scores indicate worse outcomes.

    Measured: Baseline (Day of Discharge) and POD 30（30 days 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 posted2 Mar 2026
  2. Study start10 Feb 2026
  3. Primary completion10 Mar 2027 (estimated)
  4. Study completion30 Jun 2027 (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 N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
264 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07444099
Sponsor's protocol ID
KYLL-202501-049-1
Status last verified
Feb 2026
First submitted
10 Feb 2026
Last updated
2 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All individual participant data (IPD) underlying the published results

Publications

  • Basch E. Patient-Reported Outcomes - Harnessing Patients' Voices to Improve Clinical Care. N Engl J Med. 2017 Jan 12;376(2):105-108. doi: 10.1056/NEJMp1611252. No abstract available.

    PubMed 28076708

  • Gillis C, Ljungqvist O, Carli F. Prehabilitation, enhanced recovery after surgery, or both? A narrative review. Br J Anaesth. 2022 Mar;128(3):434-448. doi: 10.1016/j.bja.2021.12.007. Epub 2022 Jan 7.

    PubMed 35012741

  • Michard F, Thiele RH, Le Guen M. One small wearable, one giant leap for patient safety? J Clin Monit Comput. 2022 Feb;36(1):1-4. doi: 10.1007/s10877-021-00767-0. Epub 2021 Oct 19. No abstract available.

    PubMed 34665392

  • Tian Y, Cao S, Liu X, Li L, He Q, Jiang L, Wang X, Chu X, Wang H, Xia L, Ding Y, Mao W, Hui X, Shi Y, Zhang H, Niu Z, Li Z, Jiang H, Kehlet H, Zhou Y. Randomized Controlled Trial Comparing the Short-term Outcomes of Enhanced Recovery After Surgery and Conventional Care in Laparoscopic Distal Gastrectomy (GISSG1901). Ann Surg. 2022 Jan 1;275(1):e15-e21. doi: 10.1097/SLA.0000000000004908.

    PubMed 33856385

  • Sauro KM, Smith C, Ibadin S, Thomas A, Ganshorn H, Bakunda L, Bajgain B, Bisch SP, Nelson G. Enhanced Recovery After Surgery Guidelines and Hospital Length of Stay, Readmission, Complications, and Mortality: A Meta-Analysis of Randomized Clinical Trials. JAMA Netw Open. 2024 Jun 3;7(6):e2417310. doi: 10.1001/jamanetworkopen.2024.17310.

    PubMed 38888922

Questions about this trial

What is this clinical trial studying?

A study testing Early structured postoperative intervention encompassing nutrition, psychology, and exercise in people with Gastric Cancer (GC) and Postoperative Recovery, run by Qilu Hospital of Shandong 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 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: enrolling by invitation, as of the sponsor's last update on 2 Mar 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?

incidence of complications within 30 days postoperatively (time frame: 30 days after operation). The study lists 2 primary outcomes in all. 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 NCT07444099, which also lists 5 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 Mar 2026.

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