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Clinical study of Xiaoyan granule combined with Durvalumab in the treatment of advanced NSCLC

Clinical study of Xiaoyan granule combined with Durvalumab in the treatment of advanced NSCLC

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100043656
Enrollment
Unknown
Registered
2021-02-24
Start date
2021-02-24
Completion date
Unknown
Last updated
2022-10-04

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

Conditions

lung cancer

Interventions

experimental group:Xiaoyan Decoction+Durvalumab

Sponsors

The First Teaching Hospital of Tianjin University of TCM
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Aged between 18 and 75, male and female; 2.Patients with advanced NSCLC confirmed by histopathology and/or cytology; 3.Patients with wild-type lung cancer-related driving genes such as EGFR and ALK who have received at least previous radiotherapy and chemotherapy; 4.ECOG score was 0-2; 5.Patients with advanced NSCLC whose life expectancy was at least 3 months and whose TCM syndrome differentiation was qi deficiency, poison stasis type; 6.Damage recovered from other treatments; 7.The main laboratory test indexes are normal; 8.Durvalumab can be used for treatment as determined by the attending physician; 9.Signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Participated in clinical trials of other drugs within 4 weeks before the study; Or have been treated with PD-1 inhibitors, CTLA-4 inhibitors, etc.; 2. Toxicity associated with previous chemotherapy and/or radiotherapy persists; 3. Have any active autoimmune diseases or a history of autoimmune diseases; 4. Use of immunosuppressive drugs within 14 days prior to initial use of study drugs, excluding nasal spray and inhaled corticosteroids or physiological doses of systemic steroids; 5. Live attenuated vaccine was administered within 4 weeks prior to initial administration or planned during the study period; 6. Received chemotherapy or radiotherapy within 4 weeks or are currently using other anti-tumor drugs; 7. Durvalumab is known to produce allergy, hypersensitivity or intolerance; 8. Multiple factors affecting oral drug absorption (such as inability to swallow, nausea and vomiting, chronic diarrhea and intestinal obstruction, etc.).

Design outcomes

Primary

MeasureTime frame
Objective Response Rate;Disease Control Rate;

Countries

China

Contacts

Public ContactLi Xiaojiang

The First Teaching Hospital of Tianjin University of TCM

zxqlovelxj@126.com+86 22 27986535

Outcome results

None listed

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