Shenlingcao Oral Liquid for Patients With Stage II or IIIA NSCLC

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

527 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-05

Study Completion Date

2023-05-04

Brief Summary

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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.

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Detailed Description

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Conditions

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Carcinoma, Non-Small-Cell Lung Chemotherapy, Adjuvant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention group

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

Group Type EXPERIMENTAL

Shenlingcao Oral Liquid

Intervention Type DRUG

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

Control group

Patients receive conventional adjuvant chemotherapy.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Shenlingcao Oral Liquid

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No