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A single arm, single center phase II clinical study to evaluate the efficacy of arotinib hydrochloride combined with radiotherapy in the treatment of non-small cell lung cancer

Objective to evaluate the safety and preliminary efficacy of arotinib hydrochloride combined with radiotherapy in the treatment of locally advanced non-small cell lung cancer

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100043364
Enrollment
Unknown
Registered
2021-02-11
Start date
2020-07-01
Completion date
Unknown
Last updated
2021-06-07

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

Conditions

Non-small cell lung cancer

Interventions

A single arm:Arotinib combined with radiotherapy

Sponsors

Clinical Trial Management Public Platform
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age: 18-80 years old; gender is not limited; ECoG score <= 3. 2. Stage III NSCLC confirmed by histology or cytology (according to AJCC 8th Edition) which is inoperable or refused to be operated; 3. Patients with wild-type genes or patients without previous use of PD1 or PDL1 immunosuppressants; 4. The damage caused by other treatments has recovered, and the end of chemotherapy is more than 4 weeks; 5. No serious cardiovascular and cerebrovascular disease, normal liver and kidney function. 6. The subjects volunteered to join the study and signed informed consent, with good compliance and follow-up.

Exclusion criteria

Exclusion criteria: 1. The patients with EGFR, ALK and ros1 gene mutation are suitable for targeted therapy; 2. Patients who can not accept radical radiotherapy for various reasons; 3. Non small cell lung cancer patients with hemoptysis (> 50 ml / day); tumor with cavity or obvious necrosis; or imaging showed that important blood vessels had been invaded by tumor or researchers determined that tumor might invade important blood vessels during follow-up, causing fatal bleeding; 4. There are obvious factors affecting oral drug absorption, such as inability to swallow, chronic diarrhea and intestinal obstruction; 5. The estimated survival time was less than 6 months.

Design outcomes

Secondary

MeasureTime frame
Progression free survival, PFS;overall survival, OS;

Primary

MeasureTime frame
Objective response rate, ORR;Disease Control Rate, DCR;

Countries

China

Contacts

Public ContactNingpeng

Baoji Gaoxin Hospital

279119@qq.com+86 13772630041

Outcome results

None listed

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