Observation on the Therapeutic Effect of Huaier Granules in the Adjuvant Treatment of Non-small Cell Lung Cancer After Radical Surgery

Recruiting now

Conditions studied: Non-small Cell Lung Cancer

In brief

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 platinum dual-drug chemotherapy.

Key facts

Study ID

NCT06109454

Run by

Liaoning Cancer Hospital & Institute

People needed

240

Starts

2024-03-21

Expected to finish

2028-10-01

Last updated by the study team

2024-05-10

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Liaoning Cancer Hospital & Institute — Shenyang, Liaoning, China (enrolling)

Full record on ClinicalTrials.gov

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