Lifei Xiaoji Wan in Treatment of Advanced NSCLC

NCT06406166 | Recruiting DMC

• 1 other identifier: TCM for advanced NSCLC
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to evaluate the clinical efficacy of Lifei Xiaoji Wan for advanced non-small cell lung cancer (NSCLC), establish the treatment scheme, and obtain high-quality clinical evidence.

Conditions

Advanced Non Small Cell Lung Cancer

Keywords

advanced non small cell lung cancer; traditional Chinese medicine; randomized controlled trial

Outcome Measures

Primary Outcomes (2)

• Overall survival

  Time from enrollment to patient death.

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year.

• Progression-free survival

  Time from enrollment to objective tumor progression or all-cause death.

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year.

Secondary Outcomes (13)

• Functional Assessment of Cancer Therapy-Lung (FACT-L)

  Change from baseline the scores of FACT-L at month 2, 4, 6, 8, 10 and 12.

• TCM symptoms and syndrome

  Change from baseline the TCM symptoms and syndrome at month 2, 4, 6, 8, 10 and 12.

• Response Evaluation Criteria in Solid Tumours (RECIST)

  Change from baseline the RECIST at month 2, 4, 6, 8, 10 and 12.

• Tumor markers CEA

  Change from baseline the levels of tumor markers at month 2, 4, 6, 8, 10 and 12.

• Tumor markers CA211

  Change from baseline the levels of safety indicators at month 2, 4, 6, 8, 10 and 12.

Study Arms (2)

trial group

EXPERIMENTAL

The patients in the trial group received routine Western medicine treatments, and oral Lifei Xiaoji Wan (10 pills/time, 3 times/day).

Drug: Lifei Xiaoji Wan; Other: Conventional treatment with Western medicine

control group

NO INTERVENTION

The patients in the control group received routine Western medicine treatments.

Interventions

Lifei Xiaoji Wan DRUG

The Lifei Xiaoji Wan consists of ginseng, blackhead, rhubarb, aster, forehu, and thin on

trial group

Conventional treatment with Western medicine OTHER

Conventional treatment with Western medicine

trial group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of NSCLC.
• The tumor stage (TNM) stage is from III to IV.
• years old.
• The expected survival period is\> 3 months.

You may not qualify if:

• Early-stage patients with prior surgery and no recurrence.
• Patients with serious dysfunction of the heart, liver, heart, kidney, and other important organs.
• Mental illness and other patients were unable to complete the study.

Sponsors & Collaborators

• Henan University of Traditional Chinese Medicine: lead

Study Sites (1)

the First Affiliated Hospital of Henan University of Chinese Medicine

Zhengzhou, Henan, 450000, China

RECRUITING

Central Study Contacts

Yuanyuan Wang, MD

CONTACT

0371-66248624; 40685685@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: May 9, 2024
• Study Start: June 1, 2022
• Primary Completion: October 1, 2024
• Study Completion: December 31, 2024
• Last Updated: September 25, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)