Trials / Unknown
UnknownNCT05818982
To Evaluate the Efficacy and Safety of Afatinib for Advanced ALTRK-negative ESCC
A Multicenter, Open-label, Randomized, Controlled Phase II Study to Evaluate the Efficacy and Safety of Afatinib Versus Irinotecan as a Second-line and Above Treatment for Advanced ALTRK-negative ESCC
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 72 (estimated)
- Sponsor
- Peking University · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This is a phase II study to evaluate the effectiveness and safety of Afininib compared to irinotecan in the 3-gene RNA sequencing (ALTRK) negative advanced esophageal squamous squamous carcinoma.
Detailed description
Participants were assigned to either group A or group B at 2:1 randomization (block randomization). Group A received afatinib (40 mg orally/day) every 6 weeks; Group B received irinotecan (140-180mg/m2 intravenous) every 2 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Afatinib | Afatinib will be administered orally at 40 mg per day (qd) in each 6-week cycle. |
| DRUG | Irinotecan | Irinotecan, intravenous drip, 140-180mg/㎡, D1, Q14D |
Timeline
- Start date
- 2023-02-09
- Primary completion
- 2025-02-01
- Completion
- 2026-02-01
- First posted
- 2023-04-19
- Last updated
- 2023-04-19
Locations
3 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05818982. Inclusion in this directory is not an endorsement.