Traditional Chinese Medicine for Prevention and Treatment of Recurrence and Metastasis of Limited Stage Small Cell Lung Cancer: a Non-Randomized Concurrent Controlled Clinical Trial in a Real World Study

Phase 1

Recruiting

• Conditions: imited Stage Small Cell Lung Cancer

• Registration Number: ITMCTR2100004759
• Lead Sponsor: Guang'anmen Hospital, China Academy of Chinese Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Aged 18-75 years.
2. Patients with limited-stage SCLC who have a clear pathological diagnosis and have received first-line treatment (standard radiotherapy and chemotherapy regimens).
3. The expected survival time is >= 6 months.
4. The ECOG score of physical strength is 0-2 points.
5. Volunteer to participate in this study and sign an informed consent form.
6. Chemotherapy >= 2 cycles, and the curative effect is evaluated as SD, PR or CR.

Exclusion Criteria

1. Combined with serious diseases such as heart, liver, kidney and hematopoietic system.
2. Patients who are known to be allergic to the study medication.
3. Children, pregnant women, psychiatric patients and patients suffering from other malignant tumors.
4. Patients who are undergoing other drug trials.
5. Patients who have completed lung cancer surgery.
6. Patients whose curative effect is evaluated as PD after chemotherapy.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-free survival;

Secondary Outcome Measures

Name	Time	Method
Overall survival;Neuron-specific enolase, NSE;Physical condition score;Evaluation of TCM symptoms;pro-GRP;Survival after progression;Recurrence and metastasis rate;Life quality evaluation;Imaging evaluation;