Clinical trial NCT03198117: Huaier Granule for Prevention of Recurrence and Metastasis of Stage II and III Non-small Cell Lung Cancer (NSCLC)
Official title: Huaier Granule for Prevention of Recurrence and Metastasis of Stage II and III NSCLC After Postoperative Adjuvant Chemotherapy: A Multicenter Randomized, Double-blind, Placebo-controlled Clinical Trial, Along With a Registration Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Qidong Gaitianli Medicines Co., Ltd
Sponsor class: INDUSTRY
First posted: 2017-06-23
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Detailed description: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: disease-free survival
timeFrame: 2-year
Secondary outcomes:
measure: overall survivals
timeFrame: 2-year
measure: Quality of Life
timeFrame: 2-year
measure: KPS
timeFrame: 2-year
measure: ECOG-PS
timeFrame: 2-year
measure: CEA
timeFrame: 2-year
measure: CYFRA21-1
timeFrame: 2-year
measure: SCC
timeFrame: 2-year
Other outcomes:
Locations:
city: Hefei
country: China
facility: Du Ying Ying
state: Anhui
Study officials:
affiliation: The First Affiliated Hospital of Anhui Medical University
name: guoping sun, doctor
role: PRINCIPAL_INVESTIGATOR
References: