NCT06042998

Brief Summary

To evaluate the clinical efficacy of robot radical Gastrectomy and laparoscopic radical Gastrectomy, patients with gastric adenocarcinoma (cT2N+M0 or cT3-4a/N+M0, phase II and III) undergoing neoadjuvant treatment were selected as subjects.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
588

participants targeted

Target at P75+ for not_applicable

Timeline
19mo left

Started Jul 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress66%
Jul 2023Dec 2027

Study Start

First participant enrolled

July 7, 2023

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

August 2, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2027

Expected
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

1.5 years

First QC Date

August 2, 2023

Last Update Submit

September 12, 2023

Conditions

Gastric Cancer Stage IIGastric Cancer Stage III

Keywords

Neoadjuvant therapygastric cancerrobot radical gastrectomylaparoscopic Gastrectomyshort-term clinical outcomeprognosis

Outcome Measures

Primary Outcomes (1)

  • 3-year disease-free survival

    3-year disease-free survival

    three years after surgery

Secondary Outcomes (3)

  • 3-year overall survival rate

    three years after surgery

  • overall postoperative morbidity rates

    30 days after surgery

  • postoperative recovery course

    14 days surgery

Study Arms (2)

Robotic group

EXPERIMENTAL

Robotic gastrectomy

Procedure: Robotic radical gastrectomy

Laparoscopic group

ACTIVE COMPARATOR

Laparoscopic gastrectomy

Procedure: Robotic radical gastrectomy

Interventions

Robotic radical gastrectomyPROCEDURE

Laparoscopic gastrectomy

Also known as: Laparoscopic gastrectomy
Laparoscopic groupRobotic group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old ≤ 75 years old male or female;
  • The primary gastric lesion was diagnosed as gastric adenocarcinoma (papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, Signet ring cell carcinoma, poorly differentiated adenocarcinoma) by endoscopic biopsy histopathology;
  • Before neoadjuvant treatment, the preoperative clinical staging was confirmed to be II and III (cT2N+M0 or cT3-4a/N+M0) through gastroscopy/ultrasound gastroscopy, enhanced CT/MR, or diagnostic laparoscopic exploration (based on AJCC-8th TNM tumor staging);
  • cycles of neoadjuvant therapy (chemotherapy+/- targeted/immunotherapy, simple chemotherapy);
  • After new adjuvant treatment, radical Gastrectomy is feasible after MDT discussion;
  • Preoperative ECOG physical condition score of 0/1 or Karst score ≥ 70%;
  • Preoperative ASA score I-III;
  • The expected survival period exceeds 6 months;
  • Willing and able to comply with the research protocol;
  • Sign a written informed consent form before enrollment and be fully aware of the right to withdraw from this study at any time.

You may not qualify if:

  • Pregnant or lactating women;
  • Suffering from serious mental illness;
  • History of upper abdominal surgery (excluding history of laparoscopic cholecystectomy);
  • History of gastric surgery (excluding ESD/EMR for gastric cancer);
  • Moderate to severe renal insufficiency;
  • Organ transplant recipients receiving immunosuppressive therapy;
  • Have a history of other malignant diseases within 5 years;
  • Have a history of unstable angina or myocardial infarction within 6 months;
  • Have a history of cerebral infarction or cerebral hemorrhage within 6 months;
  • Have a history of continuous systemic corticosteroid therapy within one month;
  • Simultaneous surgical treatment of other diseases is required (excluding laparoscopic cholecystectomy);
  • Gastric cancer comorbidities (bleeding, perforation, obstruction) requiring emergency surgery;
  • Lung function test FEV1\<50% of expected value;
  • The patient has participated or is currently participating in other clinical studies (within 6 months).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital

Qingdao, Shandong, 266000, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Central Study Contacts

Yanbing Zhou

CONTACT

13708971773zhouyanbing999@aliyun.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Group A (experimental group): Performing robot radical gastrectomy Group B (control group): Performing laparoscopic radical gastrectomy
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2023

First Posted

September 21, 2023

Study Start

July 7, 2023

Primary Completion

December 30, 2024

Study Completion (Estimated)

December 30, 2027

Last Updated

September 21, 2023

Record last verified: 2023-09

Locations

CN(1)