Shenlingcao Oral Liquid for Patients With Stage II or IIIA NSCLC

Sichuan University

Status and phase: Completed; Phase 4

Conditions: Chemotherapy, Adjuvant; Carcinoma, Non-Small-Cell Lung

Treatments: Drug: Shenlingcao Oral Liquid

Study type: Interventional

Funder types: Other

Identifiers

NCT03712969

20181009

Details and patient eligibility

About

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.

Enrollment: 527 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 or older;
• Pathological diagnosis of patients with stage II, III A primary NSCLC;
• R0 resection has been accepted;
• Received adjuvant chemotherapy or adjuvant chemotherapy for the first time after surgery;
• Informed consent has been signed.

Exclusion criteria

• Incorporation of other malignant tumors (such as leukemia, liver cancer, etc.);
• Patients with unclear pathological types;
• Patients with unclear pathological staging;
• Preserved Shenlingcao Oral Liquid before R0 resection surgery;
• Received immunotherapy or targeted therapy before R0 resection surgery;
• Radiotherapy and chemotherapy before R0 resection surgery.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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527 participants in 2 patient groups

Intervention group

Experimental group

Description:

Patients receive Shenlingcao oral liquid combined with conventional adjuvant chemotherapy, which take 4 courses, 30 days per course, one bottle per day.

Treatment:

Drug: Shenlingcao Oral Liquid

Control group

No Intervention group

Description:

Patients receive conventional adjuvant chemotherapy.