Shenlingcao Oral Liquid for Patients With Stage II or IIIA NSCLC
Status:
Recruiting
Trial end date:
2025-12-15
Target enrollment:
Participant gender:
Summary
In this study, a pragmatic, open labelled, multi-center randomized controlled trial will be
conducted. The study population are stage II and IIIA NSCLC patients undergoing R0 resection
and will be scheduled for adjuvant chemotherapy. Potentially eligible patients will be
screened by the research clinicians and requested to complete and sign a consent form before
enrolment. Eligible patients who consent to participate will be randomly assigned to the
intervention group (patients receive conventional treatment and Shenlingcao oral liquid) and
the control group (patients only receive conventional treatment) designed dynamic stratified
block randomized algorithm via a central randomization system for clinical research using 1:1
ratio.
The intervention and control group will be enrolled before the first chemoradiation.
Non-allelic follow-up will be conducted in this study and terminated when the last enrolled
patient follow up to 24 months. Prospectively collected information from patients, including
baseline, chemoradiation, use of Shenlingcao Oral Liquid and the other complementary drugs,
and various outcome measures (the questionnaire of EORTC QLQ, death, tumor recurrence, tumor
metastasis, and chemotherapy-induced side effects of the blood system, etc.). Follow-up
points included: Baseline (before giving chemotherapy), 2-3 days after each chemotherapy
cycle, and 6,12,18,24,30,36 months after enrollment.