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Docetaxel and capecitabine chemotherapy combined with local radiotherapy for initial unresectable locally advanced gastric cancer or para-aortic lymph node metastatic gastric cancer stage I clinical study

Docetaxel and capecitabine chemotherapy combined with local radiotherapy for initial unresectable locally advanced gastric cancer or para-aortic lymph node metastatic gastric cancer stage I clinical study

Status
Active, not recruiting
Phases
Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900021580
Enrollment
Unknown
Registered
2019-02-28
Start date
2019-03-27
Completion date
Unknown
Last updated
2019-03-04

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

Conditions

gastric carcinoma

Interventions

Case series:Docetaxel + capecitabine

Sponsors

Sichuan Provincial Tumor Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. For histologically diagnosed gastric cancer, clinical staging was performed according to endoscopic ultrasonography and enhanced CT/MRI examination, with cT4aN+M0, cT4bNanyM0, or cTxNxM1c (lymph node metastasis in 16 groups); 2. Good general condition, ECOG PS score: 0-1; 3. Non-bedridden male or female patients aged 18-75 years; 4. Physical condition and organ function allow larger abdominal surgery; 5. Subjects' baseline blood routine and biochemical indexes met the following standards: WBC > 3.5 10^9/L, ANC > 1.5*10^9/L, Hb 100g/L, PLT 100*10/L, serum bilirubin 1.5 normal high limit, AST, ALT 2.5 normal high limit, creatinine 1.0 normal high limit; 6. No history of other malignant tumors; 7. Written informed consent is provided prior to study screening, and the patient is aware of the responsibilities available for study; 8. Women of child-bearing age must undergo a pregnancy test (serum or urine) 7 days before enrollment, which is negative, and are willing to use appropriate contraception during the trial and 8 weeks after the last dose. For men, surgical sterilization was performed or an appropriate method of contraception was agreed during the trial or 8 weeks after the last administration; 9. Life expectancy 3 months; 10. Subjects voluntarily participated in this study and signed the informed consent, with good compliance and follow-up.

Exclusion criteria

Exclusion criteria: 1. The pregnant or lactating women are in the reproductive period and have not taken effective contraceptive measures; 2. Received anti-cancer treatment before enrollment; 3. Previous or concurrent malignant tumor;Previous or concurrent malignancy other than cured basal cell carcinoma of the skin and carcinoma in situ of the cervix; 4. Mental abnormalities, brain metastasis, meningeal metastasis; 5. Serious and uncontrolled medical diseases and infections;Patients with severe cardiovascular disease and uncontrollable diabetes; 6. Major organ failure, such as decompensated heart, lung, liver and kidney failure; 7. Participated in another clinical trial within 4 weeks before the start of treatment; 8. Patients with radiation/chemotherapy contraindications or surgery contraindications. 9. Activity HBV or HCV. 10. Patients with peripheral neuropathy (nct-ctcae 2). Chronic bowel disease or short bowel syndrome. 12.DPD enzyme deficiency. 13. Allergic to docetaxel or fluorouracil;

Design outcomes

Primary

MeasureTime frame
MDT;DLT;

Countries

China

Contacts

Public ContactShen Yali

Sichuan Provincial Tumor Hospital

sylprecious@163.com+86 15828155697

Outcome results

None listed

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