Clinical trial
A Phase II/III Clinical Study to Evaluate the Efficacy and Safety of Fruquintinib in Combination With Sintilimab Versus Axitinib or Everolimus as Second-line Treatment for Locally Advanced or Metastatic Renal Cell Carcinoma (FRUSICA-2)
Name
2022-013-00CH1
Description
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.
Trial arms
Trial start
2022-10-27
Estimated PCD
2024-11-01
Trial end
2025-03-01
Status
Recruiting
Phase
Early phase I
Treatment
fruquintinib+sintilimab
fruquintinib, 5 mg, QD, PO, 2 weeks on/1 week off, 3 weeks/cycle; sintilimab, 200 mg, IV infusion, Q3W, 3 weeks/cycle.
Arms:
Investigational arm
Other names:
HMPL-013 + IBI308
axitinib / everolimus
axitinib, 5 mg, twice daily (BID), PO, 3 weeks/cycle, dose escalation will be at the investigator 's discretion based on clinical; everolimus, 10 mg, QD, PO, 3 weeks/cycle.
Arms:
Control arm (comparator)
fruquintinib
fruquintinib, 5 mg, QD, PO, 3 weeks on/ 1 week off, 4 weeks/cycle.
Arms:
Fruquintinib monotherapy factorial study
Other names:
HMPL-013
Size
264
Primary endpoint
Progression free survival (PFS) in Part I
Time from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 20 months.
Objective response rate (ORR) in Part II
Time from the date of first treatment administration until disease progression or the introduction of a new treatment, assessed up to 20 months.
Eligibility 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. Had previously received therapy targeting immune modulatory receptors or related pathways (including but not limited to therapy targeting PD-1, CTLA-4, IDO, PD-L1, LAG-3, TIGIT, IL-2R and GITR, etc, but excluding related cytokine therapy such as IL2), excluding patients who had received immunotherapy such as anti-PD- (L) 1 antibody in adjuvant/neoadjuvant therapy setting and did not progress within 6 months after discontinuation;
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. Toxicities caused by prior anti-tumor therapy before the first dose that did not recover to Grade 0 or 1 per the National Cancer Institute Common Terminology Criteria for Adverse events (NCI CTCAE) v5.0 or to the level specified in the enrollment criteria (excluding alopecia and peripheral neurotoxicities ≤CTCAE Grade 2 caused by platinum-based chemotherapy; thyroid dysfunction with stable disease control after symptomatic treatment);
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 264, 'type': 'ESTIMATED'}}
Updated at
2024-03-28
1 organization
Organization
Hutchison Medipharma