Status:
RECRUITING
Observation on the Therapeutic Effect of Huaier Granules in the Adjuvant Treatment of Non-small Cell Lung Cancer After Radical Surgery
Lead Sponsor:
Liaoning Cancer Hospital & Institute
Collaborating Sponsors:
LinkDoc Technology (Beijing) Co. Ltd.
Huazhong University of Science and Technology
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Brief Summary
This study is a multicenter, prospective, and observational clinical study aimed at exploring whether the 3-year DFS in the Huaier group is not inferior to the control group receiving standard platinu...
Detailed Description
This study is a small sample observational study, mainly exploring whether the 3-year DFS of the Huaier group is not inferior to the control group receiving standard platinum dual drug chemotherapy. T...
Eligibility Criteria
Inclusion
- 18 years old ≤ age ≤ 75, regardless of gender.
- Confirmed as non-small cell lung cancer by histopathology, with pathological staging of stage Ⅱ-ⅢA.
- Received radical R0 resection of lung cancer within 2 months before enrollment, and did not receive any postoperative adjuvant therapy or preoperative neoadjuvant therapy.
- ECOG（Eastern Cooperative Oncology Group）score:0-2.
- The patient voluntarily participated in the study, agreed to cooperate with the researcher for data collection, and signed an informed consent form.
Exclusion
- Known to be allergic to the components of Huaier granules or avoid or use Huaier granules with caution (Huaier group).
- Those who have difficulty swallowing, complete or incomplete gastrointestinal obstruction, active gastrointestinal bleeding, perforation, and other causes of difficulty in taking oral medication.
- Non-small cell lung cancer patients who plan to receive targeted therapy, immunotherapy, chemotherapy combined with immunotherapy, radiotherapy, synchronous radiotherapy and chemotherapy during the study period.
- The patient has a history of other new malignant tumors within 5 years.
- The expected survival time of the patient is less than half a year.
- Surgical complications that have not recovered or are accompanied by severe infections after radical resection of lung cancer.
- Pregnant or lactating women or planned pregnancy preparation.
- The patient has received other traditional Chinese patent medicines and simple preparations with anti-tumor effect in the past one month (including but not limited to compound cantharidin capsule, cinobufagin capsule, Kangai injection, Brucea javanica injection, etc., the specific instructions shall prevail).
- The patient suffers from severe mental illness or other reasons that the researcher deems unsuitable to participate in this study.
Key Trial Info
Start Date :
March 21 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2028
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT06109454
Start Date
March 21 2024
End Date
October 1 2028
Last Update
May 10 2024
Active Locations (1)
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1
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, China, 110801