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Clinical Study on the Treatment of Stage IV Gastric Cancer with De-Walled Ganoderma Spore Powder and Chemotherapy

Clinical Study on the Treatment of Stage IV Gastric Cancer with De-Walled Ganoderma Spore Powder and Chemotherapy

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035605
Enrollment
Unknown
Registered
2020-08-14
Start date
2020-08-17
Completion date
Unknown
Last updated
2020-08-31

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

Conditions

Gastric Cancer

Interventions

Sponsors

The First Affiliated Hospital of Zhejiang Chinese Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. It is in accordance with the diagnostic criteria in the diagnostic and therapeutic specifications for gastric cancer (2018 Edition), according to the American Joint Committee on cancer (AJCC) / International Union against cancer (iajcc), According to the TNM staging system of gastric cancer, the patients who were diagnosed as stage IV by pathology or cytology and received chemotherapy or relapsed gastric cancer but did not receive systemic chemotherapy; 2. Patients with at least one measurable lesion according to recist1.1 standard; 3. Patients older than 18 years old, regardless of gender; 4. Patients with good general condition, KPS > 60 and expected survival time > 3 months; 5. The functional level of main organs meets the following standards: (1) The blood routine examination standard should meet: WBC >= 4.0 * 10^9 / L or ANC >= 1.5 * 10^9 / L, PLT >= 80 * 10^9 / L, Hb >= 90 g / L (2) Biochemical examination should meet the following criteria: TBIL = 50ml / min (Cockcroft Gault formula); 6. The subjects volunteered to participate in the study, signed the informed consent form, had good compliance and cooperated with the follow-up.

Exclusion criteria

Exclusion criteria: 1. Patients with other tumor history within 5 years; 2. Patients complicated with any acute or chronic diseases or mental disorders or laboratory examination abnormalities, which may increase the risk of participating in the study or study drug use, or affect the research results, and the patients are judged to be not suitable for the study. These include: (1) Uncontrolled hypertension, unstable angina, myocardial infarction, or symptomatic congestive heart failure or uncontrollable arrhythmias in the past 12 months. ECG showed obvious ischemic changes; (2) The active period of bacterial, fungal or viral infection; (3) Having dementia or major mental state changes that make them unable to understand or express informed consent; 3. Pregnant or lactating patients; 4. Patients who were considered unsuitable to participate in the trial; 5. The researcher judges other situations that may affect the research progress and result judgment.

Design outcomes

Primary

MeasureTime frame
Progression Free Survival;

Secondary

MeasureTime frame
Overall Survival;One-year survival rate;Chemotherapy completion rate;Systemic State Evaluation;Quality of life;TCM syndrome score of gastric cancer;Intestinal flora analysis;

Countries

China

Contacts

Public ContactShanming Ruan

The First Affiliated Hospital of Zhejiang Chinese Medical University

shanmingruan@zcmu.edu.cn+86 13588285300

Outcome results

None listed

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