Traditional Chinese Medicine Combined With Thermal and Cold Ablation for Early-stage Lung Cancer

NCT05097417 | Unknown

• 1 other identifier: 2021SH10
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

Lung cancer is the leading cause of cancer related mortality. At present, surgical treatment is the main choice for early-stage lung cancer. Even after surgery, the 5-year recurrence rate is still as high as 18.4%-24%. Traditional Chinese medicine combined with thermal and cold ablation could be an alternative treatment. Small sample clinical cases verified that this therapy could be an efficacy and safe treatment in a short period. The primary aim of this trial is to evaluate the efficacy of traditional Chinese medicine combined with thermal and cold ablation for patients with stage I non-small cell lung cancer.

Conditions

Non-small Cell Lung Cancer Stage I

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  Response were evaluated in this study using the revised international criteria (1.1) proposed by the RECIST (Response Evaluation Criteria in Solid Tumours) committee. BEST RESPONSE from the start of study treatment until the end of treatment were reported. Objective response rate is the sum of CR + PR divided by the total number of patients in each group.

  2 years after ablation

Secondary Outcomes (1)

• DFS

  2 years after ablation

Study Arms (2)

traditional Chinese medicine combined with thermal or cold ablation

EXPERIMENTAL

Combination Product: traditional Chinese medicine and ablation in the primary tumor sites

thermal or cold ablation

ACTIVE COMPARATOR

Procedure: ablation

Interventions

traditional Chinese medicine and ablation in the primary tumor sites COMBINATION_PRODUCT

Patients will be treated with traditional Chinese medicine and ablation in the primary tumor sites

traditional Chinese medicine combined with thermal or cold ablation

ablation PROCEDURE

Patients will be treated with ablation in the primary tumor sites

thermal or cold ablation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient can understand and voluntarily join the study, sign the informed consent form, and the compliance is good.
• Patients with lung nodule.
• Maximum diameter of lung nodule ≥8mm.
• The pathology of lung nodules biopsy was non-small cell lung cancer.
• I period according to the eighth edition of the TNM staging period.
• No mediastinal lymph node metastasis.
• Eastern Cooperative Oncology Group performance status of 0 to 1.
• No prior anticancer treatments including surgery, radiation,chemotherapy or local treatments.
• Sufficient organ functions.

You may not qualify if:

• Patients with previous use of various hormones, immunosuppression or autoimmune diseases.
• Women during pregnancy or breast-feeding.
• Patients with severe heart, lung, kidney disease or other systemic diseases
• Patients with severe hemorrhagic diseases.
• Patients with a history of drug abuse or mental illness.
• Other conditions that the investigator has determined are not suitable for participation in this study

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead

Study Sites (1)

Shanghai 10th People's Hospital

Shanghai, Shanghai Municipality, 86200072, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Medicine, Chinese Traditional

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Medicine, East Asian Traditional; Medicine, Traditional; Complementary Therapies; Therapeutics

Central Study Contacts

Lihong Fan, M.D.

CONTACT

+8613661599588; fanlih@aliyun.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: senior doctor

Study Record Dates

• First Submitted: June 29, 2021
• First Posted: October 28, 2021
• Study Start: November 1, 2021
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2024
• Last Updated: October 28, 2021

Record last verified: 2021-10

Locations

CN (1)