Clinical trial · Interventional
Phase II Study of Anlotinib Versus Sunitinib in Patients With Advanced Renal Cell Carcinoma（RCC）
A Randomized, Positive-controlled, Multicenter, Phase II Study of Anlotinib(AL3818) in Patients With Advanced Renal Cell Carcinoma(RCC)
- 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)
Anlotibib (AL3818) is a kind of innovative medicines approved by State Food and Drug Administration（SFDA:2011L00661） which was researched by Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd. Anlotinib is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR2、VEGFR3、PDGFRβ and c-Kit. It has the obvious resistance to new angiogenesis. The trial is to compare the efficacy and safety profile between Anlotinib and Sunitinib in patients with advanced Renal Cell Carcinoma(RCC).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anlotinib | — | UNRESOLVED | — |
| RCC | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anlotinib | Drug | — | UNRESOLVED |
| Sunitinib maleate | Drug | Sunitinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- 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
- ACTIVE_COMPARATOR
- label
- Sunitinib maleate
- description
- Sunitinib 50 mg qd p.o., 4 weeks out of 6.The treatment continued until disease progression or intolerable toxicity happened or patients withdrawal of consent.
- interventionNames
- Drug: Sunitinib maleate
Primary outcomes (1)
- 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: * 1.Patients with histologically confirmed advanced renal cell carcinoma including clear cell component and not available for surgery * 2.Without drug treatment for RCC or chemotherapy/cytokine therapy failure or resistant patients) * 3.With measurable disease (using RECIST1.1) * 4.18-75years,ECOG PS:0-1,Life expectancy of more than 3 months * 5.Other cytotoxic drugs,radiation therapy,or surgery≥4 weeks * 6.main organs function is normal * 7.Signed and dated informed consent Exclusion Criteria: * 1.Previously received targeted therapy of the metastatic renal cell carcinoma (such as sunitinib, Sorafenib) * 2.patients has many influence factors toward oral medications * 3.Known brain metastases * 4.patients with severe and failed to controlled diseases,including: suboptimal blood pressure control;suffering from myocardial ischemia or above grade I myocardial infarction, arrhythmias and Class I heart failure;activity or failure to control severe infections;liver disease such as cirrhosis, decompensated liver disease, chronic active hepatitis;poorly controlled diabetes (FBG)\>10mmol/L);urine protein≥++,etc. * 5.patients failed to heal wounds or fractures for Long-term * 6.patients occurred venous thromboembolic events within 6 months * 7.patients has HIV-positive or organ transplantation
References
Publications (1)
- DERIVEDLin J, Fang Q, Zheng X. Cost-effectiveness analysis of anlotinib versus sunitinib as first-line treatment for metastatic renal cell carcinoma in China. PLoS One. 2023 Feb 7;18(2):e0281402. doi: 10.1371/journal.pone.0281402. eCollection 2023. PMID 36749752