Efficacy and Safety of Fruquintinib in Combination With Sintilimab in Advanced Renal Cell Carcinoma

• Status: Not yet recruiting
• Trial end date: 2025-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The study consists of two parts, the first part is a randomized, open-label, active-controlled study to evaluate the efficacy and safety of Fruquintinib in combination with Sintilimab versus axitinib or everolimus montherapy as second-line treatment for locally advanced or metastatic renal cell carcinoma. The second part is a Fruquintinib montherapy factorial cohort study to evaluate the efficacy and safety of Fruquintinib monotherapy as for second-line treatment of locally advanced or metastatic renal cell carcinoma.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hutchison Medipharma Limited
• Treatments: Axitinib; Everolimus

Criteria

Inclusion Criteria:

1. 18 to 75 (inclusive) years of age on the date when ICF was signed;

2. Histologically or cytologically confirmed renal clear cell carcinoma;

3. Patients with locally advanced/metastatic renal carcinoma;

4. Patients with renal carcinoma who progressed during or after or intolerant to previous first-line VEGFR-TKI therapy for advanced/metastatic disease;

5. At least 1 measurable lesion according to RECIST 1.1;

6. ECOG PS of 0 or 1;

7. Adequate organ function.

Exclusion Criteria:

1. For patients in the first part of the randomized controlled study: has previously received therapy targeting immune modulatory receptors or related pathways;

2. Receiving approved systemic anti-tumor therapy within 2 weeks prior to the first dose;

3. Toxicities caused by prior anti-tumor therapy before the first dose that did not recover to Grade 0 or 1 per the NCI CTCAE v5.0 or to the level specified in the enrollment criteria (excluding alopecia and peripheral neurotoxicity ≤ CTCAE Grade 2);

4. Immunosuppression medication within 4 weeks prior to randomization;

5. Patients with active autoimmune or inflammatory diseases;

6. Known central nervous system (CNS) metastasis;

7. History of pneumonitis requiring corticosteroid therapy, or history of or current interstitial lung disease, or current active pulmonary infection, etc.;

8. Known clinically significant history of hepatopathy, including active hepatitis virus infection, or other active hepatitis, clinically significant moderate to severe liver cirrhosis;

9. Human Immunodeficiency Virus (HIV) Infection (HIV 1/2 Antibody positive);

10. Uncontrolled hypertension despite standard therapy;

11. Patient with evidence or history of haemorrhagic tendency within 2 months prior to the first dose, regardless of severity.