NCT04710758 Multicenter Study on Laparoscopic Total Gastrectomy for Advanced Gastric Cancer
| NCT ID | NCT04710758 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai Zhongshan Hospital |
| Condition | Stomach Neoplasms |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,018 participants |
| Start Date | 2021-01-20 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,018 participants in total. It began in 2021-01-20 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
CLASS-07 trial is a prospective, multicenter, randomized controlled trial for comparison of long-term outcomes between laparoscopic total gastrectomy (LTG) and open total gastrectomy (OTG) in patients with locally advanced gastric cancer (clinical stage T2-4aN0-3M0). The primary purpose of this study is to evaluate the overall survival and determine the efficacy of LTG compared with OTG for locally advanced gastric cancer. The second purpose is to evaluate the 3-year overall survival rate, 3-year disease free survival rate, morbidity and mortality rates, 3-year recurrence pattern and postoperative recovery course of the patients enrolled in this study.
Eligibility Criteria
Inclusion Criteria: 1. Aged 18-75 years 2. Tumor located in the middle or upper third of the stomach, and curative resection is expected to be achievable by total gastrectomy with D2 lymphadenectomy (also apply to multiple primary cancers); 3. Primary lesion is pathologically diagnosed as gastric adenocarcinoma, such as papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, poorly cohesive carcinoma (including signet ring cell carcinoma and other variants), and mixed adenocarcinoma; 4. Clinical stage T2-4aN0-3M0 (According to AJCC-8th TNM staging system); 5. Expected survival \> 6 months 6. No invasion to Z-line; 7. BMI (Body Mass Index) \< 30 kg/m2 8. No history of upper abdominal surgery (except for laparoscopic cholecystectomy); 9. No prior treatment of chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc 10. Preoperative performance status (ECOG，Eastern Cooperative Oncology Group) of 0 or 1 11. Preoperative ASA (American Society of Anesthesiologists) scoring: I-III 12. Sufficient organ functions 13. Written informed consent Exclusion Criteria: 1. Preoperative examinations indicate regional fusion of enlarged lymph nodes (max diameter ≥ 3.0cm) or enlargment of spleen hilus lymph nodes 2. Women during pregnancy or breast-feeding 3. Synchronous or metachronous (within 5 years) malignancies 4. Body temperature ≥ 38℃ before surgery or infectious disease with a systemic therapy indicated 5. Severe mental disease 6. Severe respiratory disease, FEV1 \< 50% of predicted 7. Severe hepatic and renal dysfunction 8. Unstable angina pectoris or history of myocardial infarction within 6 months 9. History of cerebral infarction or cerebral hemorrhage within 6 months 10. Continuous systemic steroid therapy within 1 month (except for topical use) 11. Gastric cancer complications (bleeding, perforation, obstruction) that requiring emergency surgery 12. Patients are participating or have participated in another clinical trial (within 6 months)
Contact & Investigator
Yihong Sun, MD
PRINCIPAL INVESTIGATOR
Fudan University
Frequently Asked Questions
Who can join the NCT04710758 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Stomach Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04710758 currently recruiting?
Yes, NCT04710758 is actively recruiting participants. Contact the research team at sun.yihong@zs-hospital.sh.cn for enrollment information.
Where is the NCT04710758 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT04710758 clinical trial?
NCT04710758 is sponsored by Shanghai Zhongshan Hospital. The principal investigator is Yihong Sun, MD at Fudan University. The trial plans to enroll 1,018 participants.