Skip to content

A randomized, open-label phase III clinical study on the efficacy and safety of oxaliplatin combined with capecitabine versus docetaxel combined with Seggio in the treatment of stage IIIc gastric cancer with postoperative adjuvant chemotherapy

A randomized, open-label phase III clinical study on the efficacy and safety of oxaliplatin combined with capecitabine versus docetaxel combined with Seggio in the treatment of stage IIIc gastric cancer with postoperative adjuvant chemotherapy

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100048255
Enrollment
Unknown
Registered
2021-07-05
Start date
2021-08-01
Completion date
Unknown
Last updated
2022-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gastric cancer

Interventions

Group A:oxaliplatin plus capecitabine
Group B:docetaxel plus S-1

Sponsors

Anhui Provincial Tumor Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years; 2. After radical resection of adenocarcinoma of the stomach and gastroesophageal junction confirmed by histology or cytology, according to the AJCC/UICC staging (8th edition) TNM stage of gastric cancer is IIIc stage (T3N3bM0, T4aN3bM0, T4bN3a/N3bM0); 3. ECOG score is 0-1; 4. The organ function level must meet the following requirements: ANC>=1.5x10^9/L, PLT>=85x10^9/L, Hb>=90g/L, serum albumin>=30g/L, TBIL<=1.5xULN, ALT and AST<= 2.5xULN; 5. The operation was performed with D2 lymph node dissection with R0 resection; 6. Female subjects of childbearing age or male subjects whose sexual partners are females of childbearing age should take effective contraceptive measures throughout the treatment period and 6 months after the treatment period; 7. The patients voluntarily joined the study, signed the informed consent form, could take oral chemotherapy drugs, had good compliance, and cooperated with follow-up.

Exclusion criteria

Exclusion criteria: 1. Received chemotherapy or radiotherapy with other drugs during the perioperative period; 2. Patients who have not received chemotherapy for more than 8 weeks after surgery; 3. Patients with severe cardiovascular and cerebrovascular diseases, severe lung diseases (interstitial pneumonia, pulmonary fibrosis, severe emphysema), etc.; 4. Patients with metastases from other sites; 5. Patients with serious complications (intestinal obstruction, liver and kidney insufficiency, cerebrovascular disorder); 6. Pregnant and lactating patients; 7. Patients who are determined in the research to be unsuitable to participate in this clinical trial; 8. Received systemic systemic therapy with Chinese herbal medicines with anti-tumor indications or immunomodulatory drugs (including thymosin, interferon, interleukin, etc.) within 2 weeks before the first administration; 9. Received live attenuated vaccine within 4 weeks prior to the first study; 10. Active autoimmune disease, or known history of primary immunodeficiency; 11. Suffering from active pulmonary tuberculosis; 12. Serious infection with poor clinical control in active stage; 13. Symptomatic congestive heart failure or arrhythmia with poorly controlled symptoms; 14. Hypertension that is still poorly controlled even with standard treatment; 15. Any arterial thromboembolic events, including myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient cerebral ischemic attack, occurred within 6 months before enrollment; 16. History of deep vein thrombosis, pulmonary embolism or any other serious thromboembolism within 3 months before enrollment 17. History of intestinal obstruction or the following diseases: inflammatory bowel disease, or extensive bowel resection, Crohn's disease, ulcerative colitis; 18. Known to have acute or chronic active hepatitis B, HBV DNA exceeding 103copies/ml, or chronic active hepatitis C; 19. History of gastrointestinal perforation or fistula within 6 months prior to inclusion.

Design outcomes

Primary

MeasureTime frame
disease free survival;

Countries

China

Contacts

Public ContactHe Yifu

Anhui Provincial Tumor Hospital

yifuhe@fsyy.ustc.edu.cn+86 18963789042

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026