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''Highly exposed Chinese herbal medicine'' combined with apatinib as maintenance treatment following first-line or second-line chemotherapy for extensive-stage small-cell lung cancer: A single-arm

Phase 2
Completed
Conditions
small cell lung cancer
Registration Number
ITMCTR2100004716
Lead Sponsor
The First Affiliated Hospital of Anhui Medical University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

The inclusion criteria were as follows:
1) with small-cell lung cancer (extensive stage);
2) aged between 18 and 70 years;
3) with at least one measurable lesion (according to the CT/MRI evaluation, the maximum diameter of the tumor was >10 mm), according to the RECIST1.1 criteria;
4) had already undergone 4-6 cycles of first-line or second-line chemotherapy, and were in the status of SD;
5) with the ECOG score of 0-2 points.

Exclusion Criteria

1) those treated with other anti-angiogenesis drugs;
2) allergic to apatinib;
3) could not tolerate long-term Chinese herbal medicine treatment;
4) accompanied with cardiovascular diseases (such as heart diseases or uncontrolled hypertension) or hematological diseases;
5) with liver or renal insufficiency;
6) with severe psychological disorders and could not adhere to the treatment;
7) with poor compliance and high risk of loss to follow up;
8) with hemorrhagic tendency;
9) underwent major surgeries within 28 d before participating in this study;
10) with perforation or abdominal fistula within 28 d before participating in this study.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Adverse reactions;Disease control rate;Correlation between high exposure to traditional Chinese medicine and PFS or OS;Objective remission rate;Progression free survival;Overall survival;
Secondary Outcome Measures
NameTimeMethod
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