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Randomized RCT Study Protocol on the Effect of Tetrandrine Injection on Radiotherapy for Thoracic Tumors

Randomized RCT Study Protocol on the Effect of Tetrandrine Injection on Radiotherapy for Thoracic Tumors

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500111007
Enrollment
Unknown
Registered
2025-10-23
Start date
2025-11-01
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

thoracic neoplasm,esophageal cancer,lung cancer

Interventions

Experimental Group:Tetrandrine Injection shall be administered continuously for 6 days followed by 1 day of drug withdrawal, starting from the initiation of radiotherapy until the end of radiotherapy,
Control group:The placebo will be administered continuously for 6 days followed by a 1-day break, starting from the initiation of radiotherapy until its completion.

Sponsors

People's Hospital of Chongqin Hechuan
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Confirmed diagnosis of thoracic malignancy by pathology or cytology, and meeting the indications for thoracic radiotherapy. 2.Aged 18–75 years, with no restriction on gender. 3.Karnofsky Performance Status (KPS) score >=70, indicating the ability to tolerate radiotherapy and related treatments. 4.Patients voluntarily participate in this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Patients with severe concurrent cardiac, hepatic, or renal insufficiency, or other serious underlying diseases. 2.Patients with allergies to tetrandrine or other related drugs. 3.Patients with a history of chronic lung diseases (such as chronic obstructive pulmonary disease, interstitial lung disease, etc.) that severely impair lung function. 4.Patients with a pulmonary infection within the past month. 5.Pregnant or lactating women. 6.Patients with poor compliance who are unable to cooperate with the completion of the study procedures.

Design outcomes

Primary

MeasureTime frame
Incidence of radiation pneumonitis;Incidence of radiological pulmonary fibrosis;

Countries

China

Contacts

Public ContactWang Guanliang

People's Hospital of Chongqin Hechuan

438850070@qq.com+86 156 8337 8560

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 30, 2026