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Jinfukang Oral Liquid Combined With Chemotherapy for Treating Driver Genenegative Advanced NSCLC

Jinfukang Oral Liquid Combined With Chemotherapy for Treating Driver Genenegative Advanced NSCLC

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400082057
Enrollment
Unknown
Registered
2024-03-20
Start date
2023-07-13
Completion date
Unknown
Last updated
2024-03-25

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

Conditions

Lung cancer

Interventions

Control group:First-line platinum-containing dual-drug chemotherapy: It is recommended to use platinum-containing
Experimental group:Jin Fukang Oral Liquid: 30ml each time, 3 times a day, 21 to 28 days 1 course, it is recommended to use at least 4 courses. The use of Jinfukang oral liquid is consistent with the c

Sponsors

Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria • 18-80 years old; Advanced non-small cell lung cancer (stage IIIB to IV) confirmed by histopathology and/or cytology; Surgical excision, judging by the researchers, the tumor tissue; • At least one measurable and evaluable target lesion (strict reference to RECIST 1.1: select the longest diameter, repeatable target lesion); • Driver gene was negative (EGFR mutation, ALK fusion, ROS1 fusion were negative); • is receiving first-line treatment with platinum-containing two-agent chemotherapy (may be combined with immunotherapy); • During first-line chemotherapy, patients who continuously used proprietary Chinese medicines with clear anti-tumor efficacy (according to the instructions) for =4 weeks could be enrolled after stopping the use of proprietary Chinese medicines, and those who > 4 weeks could be enrolled after a 4-week washout period; • TCM syndrome differentiation for Qi-yin deficiency; • Conscious, capable of language expression or reading, able to communicate normally, able to complete questionnaire assessment; • Expected survival =3 months; • Voluntary participation in the study, good compliance, signed informed consent.

Exclusion criteria

Exclusion criteria: Exclusion criteria • Known allergy to the components of the drug; • Pregnant and breastfeeding women; • Multiple brain metastases, multiple bone metastases and liver metastases, which are expected to have a greater impact on patient survival; • Participating in other drug clinical trials; • Refuse to cooperate with follow-up visits; • For other reasons, the investigator considered it inappropriate to participate in this study

Design outcomes

Primary

MeasureTime frame
PFS;

Secondary

MeasureTime frame
ORR;DCR;PS;AE;ADR;OS;

Countries

China

Contacts

Public ContactLi Hegen

Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

shlaogen@163.com+86 64385700

Outcome results

None listed

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