Clinical trial · Interventional
Study of Anlotinib in Patients With Metastatic Colorectal Cancer（mCRC）(ALTER0703)
Randomized,Double-blind,Placebo-controlled,Multicenter Study to Compare the Efficacy and Safety of Anlotinib Plus BSC Versus Placebo Plus BSC in Patients With Metastatic Colorectal Cancer Refractory to Standard Chemotherapies(ALTER0703)
NCT02332499CI-TRIAL-00038719ALTER0703completedPhase 2 / Phase 3ClinicalTrials.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)
The purpose of this study is to compare the effects and safety of Anlotinib with placebo in patients with metastatic colorectal cancer refractory to standard chemotherapies.
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 |
|---|---|---|---|
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anlotinib | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Anlotinib
- description
- Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
- interventionNames
- Drug: Anlotinib
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Overall Survival (OS)
- timeFrame
- From randomization until death (up to 24 months)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Signed and dated informed consent； 2. Histological or cytological documentation of adenocarcinoma of the colon or rectum； 3. Subjects with metastatic colorectal cancer (Stage IV),With measurable disease (using RECIST1.1)； 4. Progression during or within 3 months following the last administration of approved standard therapies which must include Fluorouracil or its derivatives, Oxaliplatin, Irinotecan； 5. ECOG PS:0-1,Life expectancy of more than 3 months； 6. main organs function is normal； 7. main organs function is normal； Exclusion Criteria: 1. Prior treatment with Anlotinib； 2. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study drug； 3. Known brain metastases； 4. patients with severe and failed to controlled diseases； 5. patients occurred venous thromboembolic events within 6 months；
References
Publications (0)
Data not yet available
No reference posted for this study.