Green Therapy of Cancer 002 (GTC002): National Key R&D Program of China: A Multicenter, Randomized Controlled Trial of Green Therapy for Stage IIIb/IV Non-Small Cell Lung Cancer (NSCLC)

A Multicenter, Randomized Controlled Trial for Green Therapy for Stage IIIb/IV Non-Small Cell Lung Cancer (NSCLC)

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR1900002370

Enrollment

Unknown

Registered

2019-05-28

Start date

2019-06-01

Completion date

Unknown

Last updated

2023-02-20

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

Conditions

stage IIIB-IV non-small cell lung cancer

Interventions

Group A:minimally invasive cryoablation and TCM

Group B:chemotherapy

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Histologic or cytologic diagnosis of NSCLC and the 8th TNM system of lung cancer staging IIIb-IV based on IASLC; (2) One of five syndromes including deficiency of both qi and yin,qi deficiency of spleen and lung, deficiency of lung yin, stagnation of qi and blood stasis and phlegm-heat obstructing lung based on the TCM diagnosis and treatment of lung cancer (2017) issued by State Administration of Traditional Chinese Medicine of the People's Republic of China; (3) At least one lesion of diameter >2cm exsiting in the lung that was capable of cryoablation; (4) Eastern Cooperative Oncology Group (ECOG) performance status less than 2 points and life expectancy of at least 3 months; (5) Aged >=18 years; (6) Patients volunteer to participate, and sign the informed consent.

Exclusion criteria

Exclusion criteria: (1) Cancer treatment including radiotherapy, chemotherapy, targeted therapy or immunotherapy within one month; (2) Symptomatic brain metastasis; (3) Poor control of infectious and radioactive inflammation around the target lesion or skin infection and ulceration at the puncture site; (4) Severe pulmonary fibrosis especially induced by drug; (5) Severe bleeding tendency, platelet less than 50×109/L and severe coagulation disorder; (6) Poor control of malignant pleural effusion in the ipsilateral of cryoablation; (7) Pregnancy or lactation, or severe dysfuction of liver, kidney, heart, lung and brain, or severe anemia, dehydration and metabolism disorders which cannot be corrected or improved in short-term , or severe systemic infection with high fever (T>38.5 degree C); (8) Antibody of HIV is positive, or other acquired/congenital immunity; (9) Organ transplantation; (10) Participating in other clinical trials within recent three months.

Design outcomes

Primary

Measure	Time frame
survival time;	—

Secondary

Measure	Time frame
progression-free survival;quality of life;Objective Response Rate;	—

Countries

China

Contacts

Public ContactHu Kaiwen

Dongfang Hospital, Beijing University of Chinese Medicine

kaiwenh@163.com+86 13911650713

Outcome results

None listed

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