Clinical trial · Interventional
Study of Anlotinib Plus Irinotecan in Patients With Esophageal Squamous Cell Carcinoma
A Randomized, Eploratory, Open Clinical Trial to Compare the Efficacy and Safety of Anlotinib Plus Irinotecan Versus Irinotecan in Patients With Esophageal Squamous Cell Carcinoma
NCT03387904CI-TRIAL-00053638unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To compare the effects and safety of Anlotinib Plus Irinotecan versus Irinotecan in patients with esophageal squamous cell carcinoma(ESCC).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Squamous Cell Carcinoma | Esophageal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anlotinib Plus Irinotecan | Drug | — | UNRESOLVED |
| Irinotecan | Drug | Irinotecan | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Anlotinib Plus Irinotecan
- description
- Anlotinib QD po.and Irinotecan Day 1,8 ivgtt. Both should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
- interventionNames
- Drug: Anlotinib Plus Irinotecan
- type
- ACTIVE_COMPARATOR
- label
- Irinotecan
- description
- Irinotecan Day 1,8 ivgtt and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
- interventionNames
- Drug: Irinotecan
Primary outcomes (2)
- measure
- Progress free survival (PFS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histological documentation of esophageal squamous cell carcinoma; * At least one measurable lesion (by RECIST1.1); * Patients who have failed to a chemoradiation treatment; * 18-75,ECOG PS:0-1,Life expectancy of more than 12 weeks; * No treated with molecular targeted drugs; * Main organs function is normal; * Patients should participate in the study voluntarily and sign informed consent; Exclusion Criteria: * Allergic to anlotinib and/or its excipients; * Patients with any severe and/or unable to control diseases,including: 1. Blood pressure unable to be controlled ideally(systolic pressure \>140 mmHg,diastolic pressure\>90 mmHg); 2. Patients with Grade 2 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias(including QT≥450ms for male, QT≥470ms for female) and patients with Grade 3 or higher congestive heart failure (NYHA Classification) or LVEF\<50%; * Patients with a clear Gastrointestinal bleeding tendency include the following situations: Local active ulcer lesions, and fecal occult blood (+ +) ; The patient had a history of black and hematemesis within 2 months; * Patients with a bleeding tendency and INR\>1.5,APTT\>1.5 ULN ; * Patients with factors that could affect oral medication (such as dysphagia,chronic diarrhea, intestinal obstruction etc.); * Patients with active brain metastasis, cancerous meningitis, spinal cord compression patients or found in Screening stage; * Patients treated with VEGFR inhibitor; * Patients with drug abuse history and unable to get rid of or Patients with mental disorders; * Patients participated in other anticancer drug clinical trials within 4 weeks; * Patients with concomitant diseases which could seriously endanger their own safety or could affect completion of the study according to investigators' judgment;
References
Publications (0)
Data not yet available
No reference posted for this study.