Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 2:19 AM
Study NCT ID:
NCT07488533
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-03-23
First Post:
2026-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing the Combination of Sullumab and Fruquintinib in Postoperative Adjuvant Therapy for High Recurrence Risk Non Transparent Renal Cell Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000591844', 'term': 'HMPL-013'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-18', 'studyFirstSubmitDate': '2026-01-19', 'studyFirstSubmitQcDate': '2026-03-18', 'lastUpdatePostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'From the date of radical nephrectomy until death from any cause, assessed up to 60 months.', 'description': 'OS will be estimated using the Kaplan-Meier method and compared with historical controls.'}], 'secondaryOutcomes': [{'measure': 'DFS', 'timeFrame': 'From randomization until disease recurrence or death, assessed up to 60 months.', 'description': 'Disease-Free Survival'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-Clear Cell Renal Cell Carcinoma']}, 'descriptionModule': {'briefSummary': '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.\n\nAfter 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.\n\nThe 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.\n\nSerplulimab 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.\n\nTreatment 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.\n\nAll 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.\n\nThis 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.\n\nThe 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.\n\nParticipation 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.\n\nThis 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.\n\nIt is hoped that this study will help better understand how to prevent kidney cancer from returning and improve survival for patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 75 years, inclusive.\n* Histologically confirmed diagnosis of non-clear cell renal cell carcinoma (non-ccRCC), including papillary, chromophobe, collecting duct, or other non-clear cell subtypes.\n* Completed radical nephrectomy (open or laparoscopic) with no evidence of residual tumor by imaging or pathology.\n* 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.\n* ECOG performance status of 0 or 1.\n* 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.\n* No prior adjuvant or neoadjuvant systemic anti-tumor therapy.\n* Willing and able to provide written informed consent and comply with study procedures.\n\nExclusion Criteria:\n\n* Pathological diagnosis of clear cell renal cell carcinoma or mixed histology with ≥20% clear cell component.\n* Evidence of distant metastasis (M1) at baseline.\n* History of active autoimmune disease (e.g., lupus, rheumatoid arthritis, inflammatory bowel disease) or current use of immunosuppressive agents.\n* Uncontrolled hypertension (systolic \\>150 mmHg or diastolic \\>100 mmHg), significant cardiovascular disease, or uncontrolled heart failure.'}, 'identificationModule': {'nctId': 'NCT07488533', 'briefTitle': 'Comparing the Combination of Sullumab and Fruquintinib in Postoperative Adjuvant Therapy for High Recurrence Risk Non Transparent Renal Cell Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'A Randomized Controlled, Multicenter Phase III Clinical Study Comparing the Combination of Sullimumab and Fruquintinib in Postoperative Adjuvant Therapy for High Recurrence Risk Non Transparent Renal Cell Carcinoma', 'orgStudyIdInfo': {'id': '2025-FXY-300'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Serplulimab + Fruquintinib Adjuvant Therapy', 'description': '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.', 'interventionNames': ['Drug: Serplulimab in combination with Fruquintinib']}], 'interventions': [{'name': 'Serplulimab in combination with Fruquintinib', 'type': 'DRUG', 'otherNames': ['Serplulimab + Fruquintinib'], 'description': '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.', 'armGroupLabels': ['Serplulimab + Fruquintinib Adjuvant Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Sun Yat-sen University Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'ZHOU FANGJIAN', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}