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A prospective multicenter randomized controlled clinical study of Xingxiao pill for intermittent chemotherapy treatment in patients with small cell lung cancer

A prospective multicenter randomized controlled clinical study of Xingxiao pill for intermittent chemotherapy treatment in patients with small cell lung cancer

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076617
Enrollment
Unknown
Registered
2023-10-13
Start date
2023-06-25
Completion date
Unknown
Last updated
2023-10-16

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:Take with rice wine or warm water. 3g at a time, twice a day. Taking time of Xingxiao Pills: According to the standard first-line chemotherapy regimen of 4 cycles for small cell lun
Control group:Conventional treatment: Adjuvant and symptomatic treatment other than chemotherapy drugs for small cell lung cancer, including but not limited to: antiemetic, analgesic, anti-sensitivity

Sponsors

Department of Respiratory and Critical Care Medicine, Seventh Medical Center, PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: All of the following criteria must be met in order to be included in the test (1) Age =18 years old, gender unlimited; (2) Patients with small cell lung cancer confirmed by histology or cytology according to the CSCO Guidelines for Diagnosis and Treatment of Small Cell Lung Cancer (2022 edition); (3) Measurable lesions that meet RECIST v1.1 criteria for evaluation; (4) Receiving standard first-line chemotherapy regimen (4 cycles) recommended by the CSCO Guidelines for Diagnosis and Treatment of Small Cell Lung Cancer (2022 edition); (5)ECOG score 0-1; (6) Expected survival of more than 6 months; (7) Agree to participate in the clinical trial and voluntarily sign the informed consent;

Exclusion criteria

Exclusion criteria: All of the following criteria must not be met in order to be included in the test (1) Clinically significant abnormal liver function, i.e., glutamic oxalacetic transaminase or alanine transaminase > 2.5 times the upper limit of normal, total serum bilirubin level > 1.5 times the upper limit of normal; (2) Clinically significant renal insufficiency, that is, serum creatinine > 1.5 times the upper limit of normal; (3) Patients with severe heart disease, i.e., patients with NYHA cardiac dysfunction rated ?-?; Unstable angina pectoris or myocardial infarction within 6 months; (4) Patients with splenectomy or other severe hematopoietic diseases; (5) Patients with uncontrolled diabetes mellitus, hypertension (systolic blood pressure > 180mmHg and/or diastolic blood pressure > 120mmHg), uncontrolled infections, and severe gastrointestinal ulcer disease; (6) Previous or current history of cancer other than lung cancer, other than cured non-melanoma skin cancer, cervical carcinoma in situ, and other cancers that have been cured for at least 5 years; (7) Mental illness patients without self-awareness, without legal capacity or limited legal capacity; (8) Patients who are pregnant, lactating or have the possibility of becoming pregnant or plan to become pregnant; (9) There are currently events in which the study drug cannot be taken orally (such as dysphagia, chronic diarrhea, intestinal obstruction, etc.); (10) Have participated in or are participating in other clinical researchers within the past 3 months; (11) The researchers thought there were any other ineligible candidates.

Design outcomes

Primary

MeasureTime frame
Objective response rate;

Secondary

MeasureTime frame
Overall survival;Score of EORTC QLQ-C30 scale;Lung cancer Symptom Scale LCSS score;Pain (VAS score);Tumor marker;Classification and Evaluation of Common Toxic and Side Effects of Anticancer Drugs (CTCAE-V4.0);

Countries

China

Contacts

Public ContactChangde

Department of Respiratory and Critical Care Medicine, Seventh Medical Center, PLA General Hospital

dechang5501@foxmail.com+86 138 1104 9022

Outcome results

None listed

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