RecruitingNCT06109454

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

Observational Study on the Efficacy and Safety of Huaier Granules Compared With Platinum Containing Dual Drug Combination Chemotherapy in Adjuvant Therapy for Resectable Stage II-IIIA Non-small Cell Lung Cancer After Radical Surgery


Sponsor

Liaoning Cancer Hospital & Institute

Enrollment

240 participants

Start Date

Mar 21, 2024

Study Type

OBSERVATIONAL

Conditions

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 platinum dual-drug chemotherapy.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study observes whether Huaier Granules — a traditional Chinese herbal medicine — help improve outcomes in patients with non-small cell lung cancer (NSCLC) who have recently had curative surgery. Participants are followed to track survival, recurrence, and quality of life. **You may be eligible if...** - You are between 18 and 75 years old with confirmed non-small cell lung cancer (stage II–IIIA) - You had curative (R0) surgery within the last 2 months and have not yet started any other treatment - Your general health status is good (ECOG 0–2) **You may NOT be eligible if...** - You are allergic to Huaier Granule ingredients - You have difficulty swallowing or gastrointestinal issues that prevent taking oral medication - You plan to receive chemotherapy, immunotherapy, radiation, or other targeted cancer drugs during the study - You have had another cancer in the last 5 years - You have taken other herbal anti-tumor medicines in the past month - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHuaier granule

The subjects voluntarily gave up postoperative adjuvant therapy, including chemotherapy, targeted therapy, immunotherapy, and radiation therapy, and agreed to take Huaier granules.The subjects took Huaier granules orally, one bag (10g) per time, three times a day. Until the end of the study, intolerable toxicity, withdrawal from the study for any reason or death, or when the researcher determines that there is no further benefit, whichever occurs first. Please refer to the drug manual for specific usage. It is recommended that patients start taking Huaier granules 1-2 weeks after surgery.

OTHERControl

The subjects received standard platinum dual drug chemotherapy.The subjects were treated with carboplatin injection (300mg/m2, intravenous injection, first day) combined with pemetrexed disodium (pathological type: adenocarcinoma, intravenous injection, 500mg/m2) or albumin bound paclitaxel (pathological type: squamous cell carcinoma, 260mg/m2, intravenous injection, first day) every three weeks, with a maximum of four cycles.


Locations(1)

Liaoning Cancer Hospital & Institute

Shenyang, Liaoning, China

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NCT06109454


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