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Clinical study on the efficacy and safety of regimen containing 5-FU/ levoleucovorin (Zuoyu ®?) in the first-line treatment of advanced gastric cancer

Clinical study on the efficacy and safety of regimen containing 5-FU/ levoleucovorin (Zuoyu ®?) in the first-line treatment of advanced gastric cancer

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078700
Enrollment
Unknown
Registered
2023-12-15
Start date
2023-12-25
Completion date
Unknown
Last updated
2023-12-19

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

Conditions

Advanced gastric cancer

Interventions

5-FU/Left folic acid (Zuoyu ) First line treatment group of the plan:Simultaneous infusion of Left folic acid and 5-FU

Sponsors

Jiangnan University Affiliated Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Male or female, aged 18-75 years old; 2. Patients with unresectable or metastatic gastric cancer confirmed by histopathology have not received chemotherapy or targeted treatment for unresectable or metastatic lesions in the past; 3. At least one measurable lesion according to RECIST 1.1 standard; 4. ECOG PS score: 0-2 points; 5. The expected survival period is greater than 3 months; 6. Patients with normal main organ function and no severe abnormalities in blood, heart, lung, liver, kidney, bone marrow, etc. Laboratory tests meet the following requirements: (1) Hemoglobin (Hb) = 90 g/L; (2) White blood cells (WBC) = 3.0 × 109/L; Neutrophil count (NEUT) = 1.5 × 109/L; (3) Platelet (PLT) = 100 × 109/L (4) Liver function (AST or ALT) level = 2.5 times the upper limit of normal value (ULN); Renal function (serum creatinine sCr) level = 1.5 times the upper limit of normal value (ULN); (5) Total bilirubin (TBIL) = 1.5 times the upper limit of normal value (ULN). 7. The subjects voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up; Researchers believe that treatment can benefit.

Exclusion criteria

Exclusion criteria: If a patient meets any of the following conditions, they will not be allowed to enter this study: 1 Individuals who have been confirmed to be allergic to the investigational drug and/or its excipients; 2. Subjects who have received or are currently receiving additional chemotherapy, radiation therapy, targeted or immunotherapy; 3. Pregnant or lactating women; 4. Patients who, according to the judgment of the researchers, are not suitable for inclusion in this study; 5. Patients with systemic internal medicine and psychiatric disorders who are not suitable for chemotherapy; 6. Patients who have participated in clinical trials of other drugs within four weeks.

Design outcomes

Primary

MeasureTime frame
ORR;

Secondary

MeasureTime frame
Progression free survival;safety;

Countries

CHINA

Contacts

Public ContactYong Mao

Jiangnan University Affiliated Hospital

9812015252@jiangnan.edu.cn+86 186 5158 1690

Outcome results

None listed

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