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A randomized controlled clinical study of Yi Shen Gu Kang Fang Formula (Yi Shen Qu Tong Granules) in the treatment of small cell lung cancer

A randomized controlled clinical study of Yi Shen Gu Kang Fang Formula (Yi Shen Qu Tong Granules) in the treatment of small cell lung cancer

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400088796
Enrollment
Unknown
Registered
2024-08-27
Start date
2024-04-20
Completion date
Unknown
Last updated
2024-09-02

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

Conditions

extensive stage small cell lung cancer

Interventions

EP regimen chemotherapy
Chinese medicine simulant
Yi Shen Qu Tong Granules

Sponsors

Cancer Hospital, Chinese Academy of Medical Sciences/Peking Union Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Meet the western medical diagnostic criteria for small cell lung cancer and Chinese medicine diagnostic criteria for renal deficiency and positive deficiency, stasis and toxicity stagnation syndrome; (2) First-line patients with evaluable lesions who have not previously received chemotherapy-targeted and immunotherapy; (3) Small cell lung cancer patients who are to receive =2 cycles of immunization + platinum + etoposide first-line treatment; (4) Uncomplicated or no previous history of other primary malignancies; (5) Age 18-80 years with expected survival >12 months; (6) Kasper score (KPS) = 60; (7) Normal cognitive ability, can cooperate in filling out the questionnaire; (8) Voluntary acceptance of the study protocol and signing of the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Those with severe cardiac or cerebrovascular disease, severe hepatic or renal impairment, or infection; (2) Those who have participated or are participating in other clinical trials within 3 months (3) Those with a history of previous psychiatric disorders such as depression, obsessive-compulsive disorder, or schizophrenia; (4) Those who require simultaneous radiotherapy; (5) Those who are pregnant or breastfeeding.

Design outcomes

Primary

MeasureTime frame
progression free survival;tumor marker;

Secondary

MeasureTime frame
TCM syndrome score ;QLQ-C30;Piper Fatigue Score;

Countries

China

Contacts

Public ContactFeng Li

Cancer Hospital, Chinese Academy of Medical Sciences/Peking Union Medical College

fengli663@126.com+86 186 1814 7576

Outcome results

None listed

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