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A multi-center clinical study of paclitaxel for injection (albumin-bound) in the treatment of patients with upper gastrointestinal tumor dystrophy

A multi-center clinical study of paclitaxel for injection (albumin-bound) in the treatment of patients with upper gastrointestinal tumor dystrophy

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000038940
Enrollment
Unknown
Registered
2020-10-10
Start date
2020-10-10
Completion date
Unknown
Last updated
2021-07-05

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

Conditions

upper gastrointestinal tumor

Interventions

Gastric Cancer/Esophageal Cancer:nutrition management

Sponsors

Anhui Provincial Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) The patient has good compliance, can understand the research process of this study, and sign a written informed consent; (2) Aged >= 18 years; (3) Gastric cancer/esophageal cancer patients diagnosed by histopathology or cytopathology; (4) The nutritional status is rated as B or C (using the PG-SGA Nutrition Evaluation Scale); (5) The expected survival period must be greater than 12 weeks; (6) According to the RECIST1.1 standard, the patient has at least one evaluable lesion; (7) KPS score >= 50 points or ECOG score = 70g/L; absolute neutrophil count (ANC) >= 1.5 x 10^9/L; platelet (PLT) >= 100 x 10^9/L; (9) Liver function standard: ALT, AST <= 2.5 x upper limit of normal (ULN), if there is liver metastasis, ALT, AST <= 5 x ULN; serum total bilirubin < 1.5 x ULN; (10) Renal function standard: serum creatinine <= 1.5 times the upper limit of normal; (11) Check that HCV-RNA was below the lower limit of detection within 2 months before enrollment, and HBV-DNA was less than 1 x 10^3; (12) Women who are not pregnant or breastfeeding; during the study period and within 6 months after the study treatment, women/men of childbearing age should take effective contraceptive measures;

Exclusion criteria

Exclusion criteria: 1. Paclitaxel for injection (albumin-bound type) is contraindicated, such as allergy to paclitaxel or albumin components contained; 2. There are serious concomitant diseases: such as those with diabetes who cannot be well controlled by hypoglycemic drugs, renal failure, liver failure, uncontrolled epilepsy, history of central nervous system disease or mental disorder, acute digestive tract Moderate and heavy bleeding, uncontrolled brain metastases, etc. For severe heart disease, it is necessary to evaluate the classification of heart function and exclude it from the group according to the specific circumstances, including but not limited to (1) Heart failure above NYHA II; (2) Myocardial infarction or unstable angina pectoris occurred within 6 months; (3) No efficacy after clinical intervention Good supraventricular or ventricular arrhythmia. 3. Peripheral neuropathy >= Grade II at present or in the past; 4. The cumulative use of yew-type drugs in the past has reached 10 cycles; 5. Participated in other clinical studies within 4 weeks before enrollment; 6. Patients considered by the investigator to be unsuitable to participate in this trial.

Design outcomes

Primary

MeasureTime frame
ORR;Nutritional status assessment PG-SGA score;AE;

Countries

China

Contacts

Public ContactLi Suyi

The First Affiliated Hospital of USTC (West District)

lisuyidoctor@163.com+86 13951872893

Outcome results

None listed

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