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Gastric Cancer (GC)NCT07328633

Prehabilitation Plus ERAS in Gastric Cancer Surgery

A study testing Pre-habilitation Program and Enhanced Recovery After Surgery (ERAS) Protocol in people with Gastric Cancer (GC), run by The Affiliated Hospital of Qingdao University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims to evaluate the impact of pre-habilitation combined with Enhanced Recovery After Surgery (ERAS) versus ERAS perioperative management alone on clinical outcomes in patients with gastric cancer undergoing neoadjuvant chemotherapy and laparoscopic (robotic) gastrectomy. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Gastric Cancer (GC)
What is being tested?
Pre-habilitation Program and Enhanced Recovery After Surgery (ERAS) Protocol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
136 participants
Where
1 siteChina
Study dates
5 Dec 2024to 30 Sep 2025
Phase
Interventional
Are there results?
None posted in the registry

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

  • Age:18-75 years
  • ECOG:0-2
  • ASA:I-III
  • Histologically confirmed gastric adenocarcinoma (cT3-4aN+M0)
  • Fit for radical surgery after MDT
  • Negative pregnancy test within one month
  • Non-pregnant or non-lactating

Who cannot join

  • Severe cardiac (LVEF<30% or NYHA IV)
  • Severe hepatic or renal dysfunction (Child-Pugh ≥10; CrCl<25 ml/min)
  • Recent cerebrovascular events
  • Concomitant tumors requiring surgery
  • Emergency surgery for tumor complications,
  • Severe infections

Trial locations and contacts

1 site in 1 country.

China1 site

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong, 266000

Other trials in China

About this study

Official title: Effect of Pre-habilitation Combined With Enhanced Recovery After Surgery (ERAS) Versus ERAS Perioperative Management on Clinical Outcomes of Laparoscopic (Robotic) Gastrectomy in Patients With Gastric Cancer Receiving Neoadjuvant Chemotherapy: A Single-center Randomized Controlled Trial

This study aims to evaluate the impact of pre-habilitation combined with Enhanced Recovery After Surgery (ERAS) versus ERAS perioperative management alone on clinical outcomes in patients with gastric cancer undergoing neoadjuvant chemotherapy and laparoscopic (robotic) gastrectomy. The study is a single-center, randomized controlled trial involving patients aged 18-75 years. Participants will be randomly assigned to either a pre-habilitation program plus ERAS or ERAS alone. The primary outcome is the incidence of postoperative complications within 30 days. Secondary outcomes include pathological data, surgical outcomes, patient-reported outcomes, and long-term survival rates.

Read the detailed description

The study is designed as a prospective, single-center, randomized, open-label, controlled clinical trial to compare the effects of pre-habilitation combined with ERAS versus ERAS alone in patients undergoing laparoscopic (robotic) gastrectomy after neoadjuvant chemotherapy for gastric cancer. The study will enroll patients aged 18-75 years who are scheduled for laparoscopic (robotic) gastrectomy following neoadjuvant chemotherapy. Participants will be randomly assigned in a 1:1 ratio to either the pre-habilitation plus ERAS group or the ERAS group. The pre-habilitation program will include a 4-week intervention involving exercise, nutrition, and psychological support prior to surgery. The primary endpoint is the incidence of postoperative complications within 30 days, assessed using the Clavien-Dindo classification. Secondary endpoints include pathological characteristics, surgical outcomes, patient-reported outcomes, and long-term survival rates. Data will be collected from patient records and follow-up visits. Statistical analysis will be performed using SPSS 26.0 or later versions, with significance level set at α=0.05.

Being tested
Pre-habilitation Program, Enhanced Recovery After Surgery (ERAS) Protocol
Keywords
Gastric Cancer, Neoadjuvant Chemotherapy, Laparoscopic Gastrectomy, Robotic Surgery, Pre-habilitation, Enhanced Recovery After Surgery (ERAS)
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • Pre-habilitation ProgramBehavioural

    A 4-week pre-habilitation program including exercise, nutrition, and psychological support aimed at improving physical and mental readiness for surgery.

  • Enhanced Recovery After Surgery (ERAS) ProtocolProcedure or surgery

    Standard protocols for Enhanced Recovery After Surgery aimed at reducing postoperative complications and accelerating recovery.

Study groups in NCT07328633
Study groupRoleWhat they receive
Pre-habilitation + ERASExperimentalParticipants will undergo a 4-week pre-habilitation program including exercise, nutrition, and psychological support, followed by Enhanced Recovery After Surgery (ERAS) protocols.
Receives: Behavioral: Pre-habilitation Program; Procedure: Enhanced Recovery After Surgery (ERAS) Protocol
ERAS OnlyActive comparatorParticipants will receive standard Enhanced Recovery After Surgery (ERAS) protocols without the pre-habilitation program.
Receives: Procedure: Enhanced Recovery After Surgery (ERAS) Protocol

What is being measured

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

  1. Incidence of Postoperative Complications

    The primary outcome measure is the incidence of postoperative complications within 30 days after surgery, assessed using the Clavien-Dindo classification system(CDC ≥ II).

    Measured: Postoperative 30-day

Secondary outcomes (11)

  1. Operation time

    Time from skin incision to skin closure. Unit: minutes.

    Measured: Intra-operative

  2. Estimated blood loss

    Total volume of intra-operative blood loss. Unit: mL.

    Measured: Intra-operative

  3. Pathological ypT stage

    Tumour infiltration depth in the resection specimen according to AJCC 8th edition.

    Unit: n (%) - categories T0, T1, T2, T3, T4.

    Measured: At pathology review (within 2 week after surgery)

  4. Pathological ypN stage

    Number of metastatic lymph nodes in the resection specimen. Unit: n (%) - categories N0, N1, N2, N3.

    Measured: At pathology review (within 2 week after surgery)

  5. AJCC pathological TNM stage

    Combined pathological stage. Unit: n (%) - stages I, II, III.

    Measured: At pathology review (within 2 week after surgery)

  6. Tumour regression grade (TRG)

    Degree of tumour response to neoadjuvant therapy according to Mandard criteria. Unit: n (%) - grades 0, 1, 2, 3.

    Measured: At pathology review (within 2 week after surgery)

  7. Time to first flatus

    Interval from end of surgery to first rectal gas passage. Unit: days.

    Measured: Post-operative period (up to 30 days)

  8. Time to first liquid diet

    Interval from end of surgery to first tolerated liquid intake. Unit: days.

    Measured: Post-operative period (up to 30 days)

  9. Post-operative hospital stay

    Interval from surgery to hospital discharge. Unit: days.

    Measured: Post-operative period.

  10. Serum albumin level

    Serum albumin measured post-operatively. Unit: g/L.

    Measured: Post-operative day 1,3,5.

  11. Tumour differentiation

    Histological grade of the tumour. Unit: n (%) - well / moderate / poor.

    Measured: At pathology review (within 2 week 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 posted9 Jan 2026
  2. Study start5 Dec 2024
  3. Primary completion30 Aug 2025
  4. Study completion30 Sep 2025

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
136 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07328633
Sponsor's protocol ID
QYFYEC2025-08
Status last verified
Dec 2025
First submitted
19 Sep 2025
Last updated
9 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data (IPD) including baseline demographics, intervention details, and all primary/secondary outcomes will be shared. No participant identifiers will be included.

Publications

  • Ajani JA, Bentrem DJ, Besh S, D'Amico TA, Das P, Denlinger C, Fakih MG, Fuchs CS, Gerdes H, Glasgow RE, Hayman JA, Hofstetter WL, Ilson DH, Keswani RN, Kleinberg LR, Korn WM, Lockhart AC, Meredith K, Mulcahy MF, Orringer MB, Posey JA, Sasson AR, Scott WJ, Strong VE, Varghese TK Jr, Warren G, Washington MK, Willett C, Wright CD, McMillian NR, Sundar H; National Comprehensive Cancer Network. Gastric cancer, version 2.2013: featured updates to the NCCN Guidelines. J Natl Compr Canc Netw. 2013 May 1;11(5):531-46. doi: 10.6004/jnccn.2013.0070.

    PubMed 23667204

  • Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

    PubMed 33538338

  • Xing J, Wang Y, Shan F, Li S, Jia Y, Ying X, Zhang Y, Li Z, Ji J. Comparison of totally laparoscopic and laparoscopic assisted gastrectomy after neoadjuvant chemotherapy in locally advanced gastric cancer. Eur J Surg Oncol. 2021 Aug;47(8):2023-2030. doi: 10.1016/j.ejso.2021.02.002. Epub 2021 Feb 6.

    PubMed 33663942

  • Zhong H, Liu X, Tian Y, Cao S, Li Z, Liu G, Sun Y, Zhang X, Han Z, Meng C, Jia Z, Wang Q, Zhou Y. Comparison of short- and long-term outcomes between laparoscopic and open gastrectomy for locally advanced gastric cancer following neoadjuvant chemotherapy: a propensity score matching analysis. Surg Endosc. 2023 Aug;37(8):5902-5915. doi: 10.1007/s00464-023-10052-7. Epub 2023 Apr 18.

    PubMed 37072637

  • Liu G, Cao S, Liu X, Tian Y, Li Z, Sun Y, Zhong H, Wang K, Zhou Y. Short- and long-term outcomes following perioperative ERAS management in patients undergoing minimally invasive radical gastrectomy after neoadjuvant chemotherapy: A single-center retrospective propensity score matching study. Eur J Surg Oncol. 2025 Jan;51(1):109459. doi: 10.1016/j.ejso.2024.109459. Epub 2024 Nov 15.

    PubMed 39566200

Questions about this trial

What is this clinical trial studying?

A study testing Pre-habilitation Program and Enhanced Recovery After Surgery (ERAS) Protocol in people with Gastric Cancer (GC), run by The Affiliated Hospital of Qingdao 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 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: finished, as of the sponsor's last update on 9 Jan 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 Postoperative Complications (time frame: Postoperative 30-day). 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 NCT07328633, 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 9 Jan 2026.

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