Huaier Granule for Prevention of Recurrence and Metastasis of Stage II and III Non-small Cell Lung Cancer (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

TERMINATED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-25

Study Completion Date

2017-11-23

Brief Summary

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This study including two parts，one part is a randomized clinical trial design，another part is a registration study.

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Detailed Description

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This study include a multicenter, randomized, controlled, double-blind, placebo-controlled post-market clinical trial and a registration study.

The randomized clinical trial included subjects (n =798) will be randomly divided into experimental (n = 532) and control groups (n =266) according to a random number table. Patients in the experimental group will receive Huaier Granule (20g/time, 3 times/d). Patients in the control group will receive placebo (20g/time, 3 times/d). The registration study plan to recruitment at least 300 patients.

The primary outcome measures is disease-free survival，secondary outcome measures is 2-year overall survivals, ECOG-performance status, Karnofsky performance score and tumor markers (CEA、CYFRA21-1、SCC).

Conditions

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Non-small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Huaier Granule

Group Type EXPERIMENTAL

Huaier Granule

Intervention Type DRUG

a Chinese traditional medicine

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

placebo

No-treatment Control

patients refused any treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Huaier Granule

a Chinese traditional medicine

Intervention Type DRUG

placebo

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients with complete resection who are at TNM (primary tumor, regional nodes, metastasis) stage II-Ⅲa, postoperative pathology confirmed for non-small cell lung cancer;
* Has completed four cycle standard solution of adjuvant chemotherapy, or refused to accept the postoperative adjuvant chemotherapy;
* Patients between 18 and 70 years old, no gender restriction;
* Eastern Cooperative Oncology Group (ECOG) PS of two or less;
* Before the start of the study, patient fully understands the study and is willing to sign the informed consent form;

Exclusion Criteria

* Receiving adjuvant chemotherapy patients started greater than 24 weeks from surgical resection;
* Refused adjuvant chemotherapy patients started greater than 8 weeks from surgical resection;
* Suspected malignant pleural effusion;
* There is no clear pathological diagnosis;
* Combined with other cancer;
* Patient have a positive surgical margin;
* Accept other treatment for lung cancer of postoperative；
* Combined with severe idiopathic disease of liver, kidney and hematopoietic system;
* Combined psychosis or AIDS;
* Allergy to the test drug;
* Pregnant or lactating women;
* Participation in any other clinical trial within three months;
* Conditions that are considered not suitable for this study investigators.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No