NCT06109454Recruiting
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
Source: ClinicalTrials.gov · Last updated 10 May 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 240 (estimated)
- First submitted
- 24 Oct 2023
- Start date
- 21 Mar 2024
- Primary completion date
- Sept 2025
- Lead sponsor
- Liaoning Cancer Hospital & Institute
- Diseases
- Lung cancer
- NCT number
- NCT06109454
What you commit to
- Study type: Observational
- Planned participants: 240
- From 21 Mar 2024 to the primary completion date, Sept 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
Other illness
- 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.
- Surgical complications that have not recovered or are accompanied by severe infections after radical resection of lung cancer.
- The patient suffers from severe mental illness or other reasons that the researcher deems unsuitable to participate in this study.
Other
- The expected survival time of the patient is less than half a year.
- Pregnant or lactating women or planned pregnancy preparation.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Liaoning Cancer Hospital & Institute Coordinator of this site? Confirm its status | Shenyang | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.