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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

''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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100004716
Enrollment
Unknown
Registered
2021-04-09
Start date
2020-01-01
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

small cell lung cancer

Interventions

Experimental group:According to the study protocol, apatinib with the initial dose of 500 mg, once per day was provided for the patients
28 days treatment was considered as one cycle. The Chinese herbal medicine Yi-Qi-Tong-Luo-Jie-Du formula (containing astragalus menbranaceus 40 g, roasted rhizoma atractylodis macrocephalae 10 g, p

Sponsors

The First Affiliated Hospital of Anhui Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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;

Countries

China

Contacts

Public ContactJiang Haili
hailijiang8911@163.com+86 18855146823

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026