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Green Therapy of Cancer 001 (GTC001): A prospective multicentre randomized controlled trial for the efficacy of minimally invasive cryoablation after first-line chemotherapy failure in advanced NSCLC based on the theory of 'treating heat with cold' of Traditional Chinese Medicine

A prospective multicentre randomized controlled trial for the efficacy of minimally invasive cryoablation after first-line chemotherapy failure in advanced NSCLC based on the theory of 'treating heat with cold' of Traditional Chinese Medicine

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800016469
Enrollment
Unknown
Registered
2018-06-02
Start date
2018-08-01
Completion date
Unknown
Last updated
2019-04-23

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

Conditions

advanced non-small-cell lung carcinoma

Interventions

Group A:minimally invasive cryoablation with TCMand supportive treatment
Group B:TCM and supportive treatment

Sponsors

Dongfang Hospital, Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. aged=18 years; 2. diagnosed NSCLC through cytology or histology; 3. The 7th TNM system of lung cancer staging IIIb or IV based on IASLC; 4. responses were evaluated as PD using RECIST after standard chemotherapy in first-line treatment according to NCCN; 5. EGFR(-) after first-line chemotherapy; 6. ALK rearranged(-)after first-line chemotherapy; 7. at least one lesion of diameter > 2cm exsiting to operate; 8. ECOG PS0~2; 9. predicted survival time > 3 months; 10. Syndrome Differentiation is deficiency of both qi and yin, intermin-gled phlegm and blood stasis; 11. participants are aware of the objective and evaluation of the study, volunteer to participate, and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Neutrophils 10×10^9/L, PLT160 mmHg or dp> 100 mmHg) before enrollment; 4. serum bilirubin is 1.5 times more than normal reference value; 5. serum creatinine is 1.5 times more than normal reference value or CCR < 50ml/min; 6. ALT or AST is 2.5 times more than normal reference value without hepatic metastases or 5 times more than normal reference value with hepatic metastases; 7. malignant pleural effusion, or hydropericardium, malignant peritoneal effusion; 8. metastatic encephaloma; 9. pregnancy or lactation; 10. antibody of HBA or HCV is positive; 11. antibody of HIV is positive, or other acquired/congenital immunity, or organ transplantation.

Design outcomes

Primary

MeasureTime frame
survival time;—

Secondary

MeasureTime frame
Response Evaluation of Solid Tumors;quality of life;changes of tumor mark levels in serum;change of TCM syndromes;evaluation of health economics;—

Countries

China

Contacts

Public ContactHu Kaiwen

Dongfang Hospital, Beijing University of Chinese Medicine, Beijing, 100078, China

kaiwenh@163.com+86 13911650713

Outcome results

None listed

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