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Synergistic effect of Ginseng Polysaccharides and immunotherapy in lung cancer

Clinical study on efficacy of PD-1 inhibitors in combination with Ginseng Polysaccharides in frontline therapy for NSCLC

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046431
Enrollment
Unknown
Registered
2021-05-15
Start date
2021-06-01
Completion date
Unknown
Last updated
2023-06-18

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

Conditions

Non-small cell lung cancer

Interventions

experimental group:Ginseng Polysaccharides and immunotherapy

Sponsors

Kiang Wu Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged from 18 to 80 years; 2. Histologically confirmed non-small cell lung cancer, metastatic or unresectable lung cancer, with measurable lesions; 3 Will receive immunotherapy as frontline therapy. 4. ECOG performance status 0 or 3 before treatment; 5 Anticipated life expectancy >= 3 month; 6. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures. Written informed consent signed.

Exclusion criteria

Exclusion criteria: 1. Diagnosed as any second primary malignant tumor in 5 years before inclusion. 2. Known infection of human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, or congenital immune deficiency diseases, organ transplantation history 3. Other severe acute or chronic physiological or psychiatric condition. 4. Existence of any disease affecting drug absorption, distribution and elimation. 5. Administration of any other anti-tumor therapy (including but not limited to radiotherapy, chemotherapy, traditional Chinese medicine, surgery, molecular targeted therapy, immunotherapy or biological therapy) 4 weeks before inclusion. 6. Long-term steroid therapy required. 7. Allergies or previous history of severe allergies to Ginseng or immunotherapy. 8. Presence of third space fluid that cannot be controlled by drainage or other means (i.e. pleural effusion or ascites); 9. Following conditions occur in the 6 months before drug administration: severe/ unstable angina pectoris, myocardial infarction, congestive heart failure with symptoms, cerebrovascular accident, including transient ischemic attack, pulmonary embolism, >= grade II renal dysfunction, and other severe diseases that investigators judged to be unsuitable for this trial; 10. Unable to receive immunotherapy or Ginseng as required, or unable to follow up in this trial.

Design outcomes

Primary

MeasureTime frame
Disease Control Rate;Overall Response Rate;

Secondary

MeasureTime frame
Progression Free Survival;

Countries

China

Contacts

Public ContactCao Yabing

Department of Oncology, Kiang Wu Hospital

sumscaoyabing@hotmail.com+853 8295 2363

Outcome results

None listed

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