Clinical trial · Interventional
Clinical Trial on Ganoderma Spore Lipids Combined With Chemo in Patients With G.I. Cancers
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A phase III double-blind randomized clinical trial on the effects of ganoderma spore lipids to the immunological response in patients with G.I. Cancers. The trial is randomized, double-blind. Cancer patients are diagnosed based on pathology or cell biology. Patients are randomized into 2 groups: both groups receive chemotherapy. Either group receives ganoderma spore lipids or placebo capsules 600mg three times a day (TID) in addition to the chemotherapy. Clinical evaluation includes chemotherapy drug toxicities, life quality improvement. Blood biochemistry tests mainly include malondialdehyde (MDA), superoxide dismutase (SOD), glutathione peroxidase (GSH-Px), adrenaline, nor-adrenaline, tumor necrosis factor (TNF)-α, interleukin (IL)-1b, interleukin (IL)-6, cell flow cytometry on Th1, Th2, Th17, Treg cytokines, as well as serum cortisol, estradiol (female), progesterone (female), testosterone (male), etc.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Neoplasms | Digestive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy | Drug | Chemotherapy | ALIAS |
| Ganoderma Spore Lipids | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- G. SPORE LIPIDS
- description
- Form: Capsule Dosage and frequency: This group receives ganoderma spore lipids capsules 600mg TID in addition to the chemotherapy. Duration: 6 chemotherapy cycles.
- interventionNames
- Drug: Ganoderma Spore Lipids
- Drug: Chemotherapy
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Form: Capsule Dosage and frequency: This group receives placebo capsules 600mg TID in addition to the chemotherapy. Duration: 6 chemotherapy cycles.
- interventionNames
- Drug: Placebo
- Drug: Chemotherapy
Primary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Age: 18-80, male and female. * Diagnosis: imaging, cell and pathology report. * Eastern Cooperative Oncology Group (ECOG) O-2, life expectancy more than 3 months. * Chemotherapy is not contraindicated. * No apparent surgical trauma during the previous 2 weeks. * Past treatment: * Biological treatment: at least 4 weeks after previous treatment with immunotherapy or other biological; chemotherapy, at least 6 months after last treatment with chemotherapy and or target therapy. * Surgery: had not received transplantation surgery, at least 2 weeks after last major surgery. Exclusion Criteria: * A purulent and chronic infection of wound healing delayed. * Diseases of the blood system. * Abnormal blood coagulation function. * Severe brain disease or primary brain tumors without control, and mentally ill person. * Patients with brain metastases. * Pregnant or lactating women. * Patients (male/female) with fertility, But the patients themselves or their spouses do not take effective contraception. * Allergic constitution. * In addition, patients taking part in other clinical trials, being treated with other biotherapy or immunotherapy and researchers consider not suitable for clinical subjects for other reasons will be excluded.
References
Publications (0)
Data not yet available