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Anlotinib combined with afatinib in the third-line treatment of advanced lung squamous cell carcinoma

Anlotinib combined with afatinib in the third-line treatment of advanced lung squamous cell carcinoma

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100042399
Enrollment
Unknown
Registered
2021-01-21
Start date
2021-06-01
Completion date
Unknown
Last updated
2021-04-26

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

Conditions

Lung squamous cell carcinoma that failed second-line chemotherapy

Interventions

experimental group:Anlotinib combined with afatinib

Sponsors

Cancer Center of Yibin Second People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. The patients who voluntarily participated in this study signed the informed consent 2. Patients aged 18-75 years old; ECoG PS score: 0-2; The expected survival time was = 12 weeks; 3. Lung squamous cell carcinoma (LSCC) was diagnosed by pathology or cytology, and the clinical stage was stage III-IV; 4. Patients who have received at least second-line anti-tumor therapy in the past, including patients with recurrent and refractory lung squamous cell carcinoma who received systemic radiotherapy and chemotherapy, targeted and immunotherapy; 5. The main organ function met the following criteria within 7 days before treatment (1) Blood routine examination standard (without blood transfusion within 14 days) Hemoglobin (HB) >= 70g / L; Absolute neutrophil count (ANC) >= 1.5 x 10^9/L Platelet count (PLT) >= 75 x 10^9/L (2) Biochemical tests should meet the following standards: Total bilirubin (TBIL) = 60ml / min; Serum albumin >= 30g / L. (3) Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) >= the lower limit of normal value (50%); (4) Other examination indexes met the requirements of medication.

Exclusion criteria

Exclusion criteria: 1. Patients with confirmed allergy to alfatinib and / or its excipients; 2. Pregnant or lactating women; 3. Patients with clinically significant bleeding symptoms or clear bleeding tendency, gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood + + or above, or vasculitis, etc. within 3 months before enrollment; 4. Patients with abnormal coagulation function (INR > 1.5 or PT > ULN + 4 seconds or APTT > 1.5 ULN), with bleeding tendency or undergoing thrombolysis or anticoagulation therapy; patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or similar drugs; patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or similar drugs; 5. Patients with a history of major surgery and trauma within 28 days; 6. Patients with wounds or fractures that have not been cured for a long time; 7. Patients with uncontrolled hypertension (systolic blood pressure >= 140 mmHg or diastolic blood pressure >= 90 mmHg, despite the best drug treatment); 8. Patients with known hereditary or acquired bleeding and thrombotic tendency (such as hemophilia, coagulation dysfunction, etc.); 9. The researcher thinks that patients should not participate in other situations of this trial.

Design outcomes

Primary

MeasureTime frame
ORR;DCR;safety;

Countries

China

Contacts

Public ContactJia Yuming

Cancer cCenter of Yibin Second People's Hospital

ybjqx3340@sina.com+86 13330663082

Outcome results

None listed

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