Comparing the Combination of Sullumab and Fruquintinib in Postoperative Adjuvant Therapy for High Recurrence Risk Non Transparent Renal Cell Carcinoma

NCT07488533 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: 2025-FXY-300
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study is testing a new treatment approach for people who have had surgery to remove a type of kidney cancer called non-clear cell renal cell carcinoma (non-ccRCC). This kind of kidney cancer is different from the most common type and tends to come back after surgery, especially in high-risk patients. After surgery, many patients are at risk of their cancer returning. Right now, there is no standard treatment to prevent this from happening. This study aims to find out if combining two medications-Serplulimab (a PD-1 inhibitor) and Fruquintinib (a targeted drug that blocks blood vessel growth in tumors)-can help reduce the chance of cancer coming back. The study will include up to 40 adults aged 18 to 75 who have had surgery to remove the tumor and are at high risk of recurrence. All participants will receive both drugs as part of an adjuvant therapy, meaning it is given after surgery to lower the risk of cancer returning. Serplulimab will be given by IV every three weeks. Fruquintinib will be taken orally daily, with a schedule of 3 weeks on and 1 week off. Treatment will last up to 12 months. Participants will be closely monitored throughout the study with regular check-ups, blood tests, imaging scans (like CT or MRI), and safety assessments. The main goal is to see how long patients stay free of cancer (called "disease-free survival"). Other goals include checking how well the treatment works, how safe it is, and whether certain biomarkers (like PD-L1 levels or genetic changes in tumor DNA) can predict who benefits most. All medical care related to the study-including visits, scans, lab tests, and the study drugs-will be provided at no cost to participants. Participants may also have access to advanced molecular testing through a partner laboratory. This is a single-center, open-label study, meaning everyone involved knows which treatment is being used. There is no placebo group; all participants receive active treatment. The study team believes this combination could offer a promising way to improve outcomes for people with high-risk non-ccRCC after surgery. If successful, it may lead to a new standard of care for this patient group. Participation is voluntary. Patients can leave the study at any time without affecting future medical care. Risks include side effects from the drugs, such as fatigue, high blood pressure, diarrhea, or immune-related reactions. The research team will monitor these carefully and provide appropriate care. This study is being conducted by researchers at a single hospital in China and supported by domestic pharmaceutical companies. It follows all national and international guidelines for ethical research involving human participants. It is hoped that this study will help better understand how to prevent kidney cancer from returning and improve survival for patients.

Conditions

Non-Clear Cell Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  OS will be estimated using the Kaplan-Meier method and compared with historical controls.

  From the date of radical nephrectomy until death from any cause, assessed up to 60 months.

Secondary Outcomes (1)

• DFS

  From randomization until disease recurrence or death, assessed up to 60 months.

Study Arms (1)

Serplulimab + Fruquintinib Adjuvant Therapy

EXPERIMENTAL

Participants in this arm will receive adjuvant therapy with Serplulimab (3 mg/kg IV every 3 weeks) and Fruquintinib (5 mg orally daily, administered on a 3-week-on/1-week-off schedule) for up to 12 months following radical nephrectomy. The treatment aims to reduce the risk of cancer recurrence in high-risk non-clear cell renal cell carcinoma patients. Safety monitoring, imaging assessments, and biomarker analyses will be conducted throughout the study period.

Drug: Serplulimab in combination with Fruquintinib

Interventions

Serplulimab in combination with Fruquintinib DRUG

This intervention consists of a combination of Serplulimab, a humanized anti-PD-1 monoclonal antibody, and Fruquintinib, a selective oral inhibitor of vascular endothelial growth factor receptors (VEGFRs). Serplulimab is administered intravenously at 3 mg/kg every 3 weeks. Fruquintinib is taken orally at 5 mg daily on a 3-week-on/1-week-off schedule. The regimen is given for up to 12 months following radical nephrectomy as adjuvant therapy in patients with high-risk non-clear cell renal cell carcinoma. The dual mechanism aims to enhance anti-tumor immunity by blocking immune checkpoint inhibition while simultaneously inhibiting tumor angiogenesis.

Also known as: Serplulimab + Fruquintinib

Serplulimab + Fruquintinib Adjuvant Therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 75 years, inclusive.
• Histologically confirmed diagnosis of non-clear cell renal cell carcinoma (non-ccRCC), including papillary, chromophobe, collecting duct, or other non-clear cell subtypes.
• Completed radical nephrectomy (open or laparoscopic) with no evidence of residual tumor by imaging or pathology.
• High-risk features defined as one or more of the following: pT3 or higher, regional lymph node involvement (N1), sarcomatoid differentiation, tumor necrosis, Fuhrman/ISUP nuclear grade ≥3, or positive surgical margin.
• ECOG performance status of 0 or 1.
• Adequate organ function: neutrophils ≥1.5 × 10⁹/L, platelets ≥100 × 10⁹/L, hemoglobin ≥9 g/dL; total bilirubin ≤1.5 × ULN; ALT/AST ≤2.5 × ULN; creatinine clearance ≥50 mL/min; INR ≤1.5.
• No prior adjuvant or neoadjuvant systemic anti-tumor therapy.
• Willing and able to provide written informed consent and comply with study procedures.

You may not qualify if:

• Pathological diagnosis of clear cell renal cell carcinoma or mixed histology with ≥20% clear cell component.
• Evidence of distant metastasis (M1) at baseline.
• History of active autoimmune disease (e.g., lupus, rheumatoid arthritis, inflammatory bowel disease) or current use of immunosuppressive agents.
• Uncontrolled hypertension (systolic \>150 mmHg or diastolic \>100 mmHg), significant cardiovascular disease, or uncontrolled heart failure.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Interventions

HMPL-013

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 19, 2026
• First Posted: March 23, 2026
• Study Start: August 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)