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Advanced Renal Cell CarcinomaPhase 2/3NCT05522231

Efficacy and Safety of Fruquintinib in Combination With Sintilimab in Advanced Renal Cell Carcinoma (FRUSICA-2)

A Phase 2/3 study testing fruquintinib+sintilimab, axitinib / everolimus and fruquintinib in people with Advanced Renal Cell Carcinoma, run by Hutchmed at 48 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 monotherapy as second-line treatment for locally advanced or metastatic renal cell carcinoma. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Advanced Renal Cell Carcinoma
What is being tested?
fruquintinib+sintilimab, axitinib / everolimus and fruquintinib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
265 participants
Where
48 sitesChina
Study dates
27 Oct 2022to 28 Aug 2026
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 18 to 75 (inclusive) years of age on the date when ICF was signed;
  • Histologically or cytologically confirmed renal clear cell carcinoma;
  • Patients with locally advanced/metastatic renal carcinoma;
  • Patients with renal carcinoma who progressed during or after or intolerant to previous first-line VEGFR-TKI therapy for advanced/metastatic disease;
  • At least 1 measurable lesion according to RECIST 1.1;
  • ECOG PS of 0 or 1;
  • Adequate organ function.

Who cannot join

  • 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;
  • Receiving approved systemic anti-tumor therapy within 2 weeks prior to the first dose;
  • 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);
  • Immunosuppression medication within 4 weeks prior to randomization;
  • Patients with active autoimmune or inflammatory diseases;
  • Known central nervous system (CNS) metastasis;
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  • History of pneumonitis requiring corticosteroid therapy, or history of or current interstitial lung disease, or current active pulmonary infection, etc.;
  • 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);
  • Human Immunodeficiency Virus (HIV) Infection (HIV 1/2 Antibody positive);
  • Uncontrolled hypertension despite standard therapy;
  • Patient with evidence or history of haemorrhagic tendency within 2 months prior to the first dose, regardless of severity.

Trial locations and contacts

48 sites in 1 country.

48 sites in 1 country

China48 sites

  • Beijing Chao-Yang Hospital, Capital Medical University

    Beijing

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing

  • Peking Union Medical College Hospital

    Beijing

  • Peking University First Hospital

    Beijing

  • Peking University Third Hospital

    Beijing

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu

  • The First Hospital of Jilin University

    Changchun

  • Hunan Cancer Hospital

    Changsha

  • Xiangya Hospital Central South University

    Changsha

  • Sichuan Provincial People's Hospital

    Chengdu

  • West China Hospital of Sichuan University

    Chengdu

  • Chongqing University Cancer Hospital

    Chongqing

  • The First Affilated Hospital of Fujian Medical University

    Fuzhou

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou

  • Sun Yat-sen University Cancer Center

    Guangzhou

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou

  • Harbin Medical University Cancer Hospital

    Ha’erbin

  • The First Affiliated Hospital, Zhejiang University

    Hangzhou

  • Anhui Provincial Hospital

    Hefei

  • The First Affiliated Hospital of Anhui Medical University

    Hefei

  • Qilu Hospital of Shandong University

    Jinan

  • Shandong Cancer Hospital & Institute

    Jinan

  • Yunnan Cancer Hospital

    Kunming

  • Lanzhou University Second Hospital

    Lanzhou

  • The First Affiliated Hospital of Nanchang University

    Nanchang

  • Jiangsu Cancer Hospital

    Nanjing

  • Jiangsu Province Hospital

    Nanjing

  • Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School

    Nanjing

  • Guangxi Medical University Cancer Hospital

    Nanning

  • Nantong Tumor Hospital

    Nantong

  • The Affiliated Hospital of Qingdao University

    Qingdao

  • Fudan University Shanghai Cancer Center

    Shanghai

  • Renji Hospital,Shanghai Jiaotong University School of Medicine

    Shanghai

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai

  • Shanghai General Hospital

    Shanghai

  • Zhongshan Hospital Fudan University

    Shanghai

  • Liaoning Cancer Hospital & Institution

    Shenyang

  • The First Hospital of China Medical University

    Shenyang

  • The Second Hospital of Tianjin Medical University

    Tianjin

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin

  • The First Affiliated Hospital of Wenzhou medical university

    Wenzhou

  • Tongji Hospital Tongji Medical College of HUST

    Wuhan

  • Wuhan Union Hospital of China

    Wuhan

  • The Second Affiliated Hospital of Xi'an Jiaotong University (Xibei Hosiptal)

    Xi'an

  • The First Affiliated Hospital of Xiamen University

    Xiamen

  • Henan Cancer Hospital

    Zhengzhou

  • Henan Provincial People's Hospital

    Zhengzhou

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou

Other trials in China

About this study

Official title: 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)

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 monotherapy as second-line treatment for locally advanced or metastatic renal cell carcinoma. The second part is a fruquintinib monotherapy 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.

Read the detailed description

The target populations for this study were patients with histologically or cytologically confirmed, locally advanced/ metastatic renal cell carcinoma who progressed during or after or intolerant to previous first-line VEGFR-TKI therapy.

A total of about 249-264 patients are planned to be enrolled in the study, among whom about 234 patients are planned to be enrolled in the first part. The patients who are successfully enrolled will be randomly assigned into the investigational arm or the control arm in a 1:1 ratio. The enrollment of part 2 will be started after that of part 1 is completed. About 15~30 patients are planned to be enrolled in the second part. The patients who are successfully enrolled will receive fruquintinib monotherapy.

Being tested
fruquintinib+sintilimab, axitinib / everolimus, fruquintinib

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • fruquintinib+sintilimabDrug

    Also called HMPL-013 + IBI308

    fruquintinib, 5 mg, QD, PO, 2 weeks on/1 week off, 3 weeks/cycle; sintilimab, 200 mg, IV infusion, Q3W, 3 weeks/cycle.

  • axitinib / everolimusDrug

    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.

  • fruquintinibDrug

    Also called HMPL-013

    fruquintinib, 5 mg, QD, PO, 3 weeks on/ 1 week off, 4 weeks/cycle.

Study groups in NCT05522231
Study groupRoleWhat they receive
Investigational armExperimentalfruquintinib, 5 mg, QD, PO, 2 weeks on/1 week off, 3 weeks/cycle; sintilimab, 200 mg, IV infusion, Q3W, 3 weeks/cycle.
Receives: Drug: fruquintinib+sintilimab
Control arm (comparator)Active comparatoraxitinib, 5 mg, twice daily (BID), PO, 3 weeks/cycle, dose escalation will be at the investigator 's discretion ;Everolimus, 10 mg, QD, PO, 3 weeks/cycle.
Receives: Drug: axitinib / everolimus
Fruquintinib monotherapy factorial studyOtherfruquintinib, 5 mg, QD, PO, 3 weeks on/ 1 week off, 4 weeks/cycle.
Receives: Drug: fruquintinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival (PFS) in Part I

    PFS per RECIST 1.1 by BIRC

    Measured: 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.

  2. Objective response rate (ORR) in Part II

    ORR per RECIST 1.1 by investigator

    Measured: Time from the date of first treatment administration until disease progression or the introduction of a new treatment, assessed up to 20 months.

Secondary outcomes (10)

  1. PFS

    PFS per RECIST 1.1

    Measured: 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.

  2. Safety in Part I

    Severity and Incidence of Adverse event (AEs) and findings in Laboratory test, vital signs, 12-lead Electrocardiogram (ECG), etc. in Part I

    Measured: Through study completion, assessed up to 20 months.

  3. Quality of life in Part I

    Quality of life questionnaire analysis in Part I, the questionnaire include European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). It consists of 30 questions, divided into 15 categories, including 5 functional categories (physical, role, emotional, cognitive, and social), 3 symptom categories (fatigue, pain, nausea and vomiting), 1 overall health status/life quality category, and 6 individual items (each item represents a symptom).

    For questions 1 to 28, the scores of 1 to 4 correspond to the levels of "none", "a little", "quite", and "very", while for questions 29 and 30, the scores of 1 to 7 correspond to the range from "very bad" to "very good". The scoring rules state that higher scores in the functional categories and overall health status category indicate better functional conditions and life quality, while higher scores in the symptom categories indicate more symptoms or problems (and poorer life quality).

    Measured: Through study completion, assessed up to 20 months.

  4. Quality of life in Part I

    Quality of life questionnaire analysis in Part I, the questionnaire include Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI-15). It was developed based on 34 symptoms related to kidney cancer, consisting of 15 questions, covering four aspects: symptom signs, respiratory symptoms, quality of life, and emotional symptoms. Each question has a score ranging from 0 to 4, corresponding to "not at all", "a little", "somewhat", "quite", and "very". The higher the score, the milder the symptoms (and the better the quality of life). The total score of the 15 individual questions ranges from 0 to 60.

    Measured: Through study completion, assessed up to 20 months.

  5. Safety in Part II

    Severity and incidence of AEs and findings in such as Laboratory test, vital signs, 12-lead ECG, etc. in Part II.

    Measured: Through study completion, assessed up to 20 months.

  6. Disease control rate (DCR)

    PFS per RECIST 1.1

    Measured: 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.

  7. ORR

    ORR per RECIST 1.1

    Measured: 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.

  8. Duration of response (DoR)

    DoR per RECIST 1.1

    Measured: 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.

  9. Time to Response (TTR)

    TTR per RECIST 1.1

    Measured: 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.

  10. OS

    OS

    Measured: Time from date of randomization until the date of death from any cause, assessed up to 20 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2022
  2. Study start27 Oct 2022
  3. Primary completion28 Aug 2026
  4. Study completion28 Aug 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
265 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05522231
Sponsor's protocol ID
2022-013-00CH1
Status last verified
Oct 2026
First submitted
16 Aug 2022
Last updated
20 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing fruquintinib+sintilimab, axitinib / everolimus and fruquintinib in people with Advanced Renal Cell Carcinoma, run by Hutchmed at 48 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (PFS) in Part I (time frame: 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05522231.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.

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