Skip to content

Phase II study of efficacy and safety of concurrent radiotherapy and anlotinib for stage III non small cell lung cancer patients who can not tolerate concurrent chemoradiation

Phase II study of efficacy and safety of concurrent radiotherapy and anlotinib for stage III non small cell lung cancer patients who can not tolerate concurrent chemoradiation

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200060712
Enrollment
Unknown
Registered
2022-06-09
Start date
2020-12-01
Completion date
Unknown
Last updated
2024-06-03

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

Group A:Thoracic radical radiotherapy+Anlotinib

Sponsors

National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-70, gender unlimited; 2. Histologically or cytologically proven stage III unresectable non-small cell lung cancer with non-squamous tissue or mixed tissue with less than 50% squamous cells; 3. EGOG =80 points, have received systemic chemotherapy for >=4 weeks; 4. Egog >=2 points, only simple radical radiotherapy can be performed; Refuse concurrent chemotherapy or cannot tolerate concurrent chemotherapy due to other comorbidies; 5. No cavity or primary tumor within 1 cm around the main blood vessel; The patient had no hemoptysis symptoms; 6. Life expectancy >6 months; 7. Satisfy the following laboratory diagnostic indicators: (1)Hemoglobin >=90 g/L, white blood cell >=3.0x10^9/L, Neutrophils >=1.5x10^9/L, platelets >=75x10^9/L; (2)Creatinine <=1.5 times the upper normal limit (UNL), total bilirubin (TBIL) <=1.5 times UNL; (3)Alanine aminotransferase (ALT), aspartate aminotransferase (AST) <= 2.5 times UNL, Alkaline phosphatase (ALP), glutamyl transpeptidase (GGT) <=2.5 times UNL; (4)Urinary protein was negative. 8. Women of childbearing age agree to use contraception during treatment; 9. Have the conditions for follow-up; 10. Signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. A history of other site malignancies being treated, excluding curable non-black pigmented skin cancer and cervical carcinoma in situ; If previous malignant tumors received radical treatment and had no recurrence for 5 years, they could be included in the group; 2. Previous chest radiotherapy; 3. Complicated with obvious hemoptysis; 4. Myocardial infarction, cerebrovascular accident, or uncontrollable and active pulmonary inflammation occurred within 3 months before enrollment; 5. Treatment regimens in current or other clinical trials participated in within 4 weeks prior to inclusion are different from those in this study; 6. Pregnant women; 7. Other nonconformities considered by the reviewers from the enrollment study to have good reason: if there are potential nonconformities with the clinical protocol.

Design outcomes

Primary

MeasureTime frame
Safety;objective remission rate;Disease progression rate and survival;

Countries

China

Contacts

Public ContactNan Bi

National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

binan_email@163.com+86 10 87787692

Outcome results

None listed

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