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Phase I clinical study for albumin paclitaxel and capecitabine chemotherapy combined with local radiotherapy for initial unresectable locally advanced gastric cancer or para-aortic lymph node metastasis

Phase I clinical study for albumin paclitaxel and capecitabine chemotherapy combined with local radiotherapy for initial unresectable locally advanced gastric cancer or para-aortic lymph node metastasis

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900023370
Enrollment
Unknown
Registered
2019-05-24
Start date
2019-06-01
Completion date
Unknown
Last updated
2019-05-27

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

Conditions

Gastric cancer

Interventions

Case series:albumin paclitaxel and capecitabine chemotherapy combined with local radiotherapy

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Histologically confirmed gastric cancer. According to endoscopic ultrasonography and enhanced CT/MRI, the clinical stage was cT4aN+M0, or cT4bNanyM0, or cTxNxM1c (16 sets of lymph node metastasis); 2) General condition and Eastern Cooperative Oncology Group (ECOG) performance status 0-1; 3) Non-bed man and woman, Age 18 to 75 years; 4) Physical condition and organ function allow for larger abdominal surgery; 5) The baseline blood routine examination and biochemical parameters of the subjects met the following criteria: WBC>3.5×10^9/L, ANC>1.5×10^9/L, Hb=100g/L, PLT=100×10/L, serum bilirubin=1.5×institutional upper limit of normal (ULN), AST and ALT=2.5×ULN, creatinine=1.0×ULN; 6) Women of childbearing age must undergo a pregnancy test (serum or urine) 7 days befroe enrollment and the results are negative, and are willing to use appropriate methods of contraception during the trial and 8 weeks after the last dos. Surgical sterilization for men, or consent to use appropriate methods of contraception during the trial or 8 weeks after the last dose; 7) The expected survival=3 months; 8) Subjects voluntarily joined the study, signed informed consent, and were well-adhered to follow-up.

Exclusion criteria

Exclusion criteria: 1) Women who are pregnant or breast-feeding during their reproductive period without effective contraception; 2) Have received anti-cancer treatment before enrollment; 3) Have had other malignant tumors at the same time ,except for cured skin basal cell carcinoma and cervical carcinoma in situ; 4) Mental disorders, brain metastasis, meningeal metastasis; 5) Serious, uncontrolled medical conditions and infections; Diabetic patients with severe cardiovascular disease and difficult to control; 6) Major organ failure, such as decompensated cardiopulmonary liver and kidney failure; 7) Participated in another clinical trial within 4 weeks before the start of treatment; 8) Have contraindications for radiotherapy/chemotherapy; 9) Active HBV or HCV; 10) Peripheral neuropathy NCT-CTCAE=2 ; 11) Chronic bowel disease or short bowel syndrome; 12) DPD enzyme deficiency; 13) Allergic to albumin paclitaxel or fluorouracil.

Design outcomes

Primary

MeasureTime frame
MDT;

Countries

China

Contacts

Public ContactYali Shen

West China Hospital, Sichuan University

sylprccious@163.com+86 18980605780

Outcome results

None listed

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