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Thyroid CancerPhase 2NCT04524884

Toripalimab Combined With Surufatinib for Locally Advanced Thyroid Cancer: a Phase II Study

A Phase 2 study testing Surufatinib and Toripalimab in people with Thyroid Cancer, run by Fudan University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study is designed to evaluate the efficacy and safety of the combination of Toripalimab and Surufatinib for Locally Advanced Thyroid Cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Thyroid Cancer
What is being tested?
Surufatinib and Toripalimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteChina
Study dates
1 Oct 2020to 30 Sep 2022
Phase
Phase 2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patient volunteered to participate in the study and signed an informed consent form and shows good compliance;
  • Age ≥18 years, male or female;
  • Pathologically diagnosed locally advanced differentiated thyroid cancer, including papillary thyroid cancer and follicular thyroid cancer;
  • Diagnosis of locally advanced disease should meet at least one of the criteria:1)Unresectable locally advanced lesion; 2)Difficult to achieve R0/R1 resection during preoperative assessment; 3)AJCC T4 stage: Primary tumor with invasion or adhesion of at least one of the following structures / organs, including: trachea, esophagus, common carotid artery, larynx, anterior vertebral fascia, brachial plexus;
  • Have at least one measurable lesion (RECIST 1.1);
  • Eastern Cooperative Oncology Group (ECOG) score 0-2;
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  • Expected survival time ≥ 12 weeks;
  • If the patient presents with distant metastasis, the value of local treatment should be assessed by the investigator;
  • The patient volunteered to receive tumor biopsy/surgery during rull-in and rull-out periods.
  • The main organ functions meet the following criteria within 7 days before treatment:1)Standard blood test (without blood transfusion within 14 days):Hemoglobin (HB) ≥90g / L; Absolute neutrophil value (ANC) ≥ 1.5 × 109 / L; Platelet (PLT) ≥80 × 109 / L; 2)Biochemical inspection must meet the following standards: Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal value (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 ULN, if with liver metastases, ALT and AST ≤ 5 ULN; Serum creatinine (Cr) ≤ 1.5 ULN or creatinine clearance (CCr)>50ml / min; 3)International normalized ratio (INR) ≤2.3 or prothrombin time (PT) prolongs less than 6 seconds; 4)Urine routine indicates urinary protein <++, and the 24-hour urine protein quantification is less than 1.0 g.
  • Women of childbearing age should agree to use contraceptives during the study; negative serum or urine pregnancy tests within 14 days before study enrollment.

Who cannot join

  • History of a second malignancy during the past 5 years before inclusion in the study or during participation in the study, with the exception of a dermal basal cell or squamous cell carcinoma or cervical carcinoma in situ, if these were curatively treated;
  • Use any anti-tumor treatment within 4 weeks (28 days) prior to the start of the study treatment, except for TSH suppression treatment;
  • Previously used any immune checkpoint inhibitors, including but not limited to pembrolizumab, nivolumab, camrelizumab, sintilimab and etc;
  • With other uncontrolled cardiac symptoms or disease;
  • Patients whose blood pressure is still unsatisfactory with a blood pressure medication (systolic blood pressure ≥140 mmHg, diastolic blood pressure ≥90 mmHg) or a history of hypertensive encephalopathy or hypertensive crisis;
  • Those who have multiple factors (such as inability to swallow) that affect oral medication;
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  • Patients with a gastrointestinal bleeding tendency including 1)Active peptic ulcer; 2)Fecal occult blood ≥ ++; 3)A history of hematemesis or melena within 3 months;
  • Coagulation disorder, such as INR greater than 1.5, or activated partial thromboplastin time (APTT) greater than 1.5 * ULN;
  • Significant hemoptysis within 2 months before screening, or the daily volume of hemoptysis reached half a teaspoon (2.5ml) or more;
  • Patients whose imaging showed that the tumor had invaded the important blood vessels or the researchers judged that the tumor was likely to invade important blood vessels during the subsequent study period and caused fatal bleeding;
  • Arterial / venous thrombosis events, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis and pulmonary embolism within 6 months;
  • Patients suffering from interstitial pneumonia or ILD, or with a history of interstitial pneumonia or ILD requiring hormone therapy, or with other pulmonary fibrosis，organic pneumonia(e.g., obliterative bronchiolitis), pneumoconiosis, drug-induced pneumonia and idiopathic pneumonia that may interfere with the diagnosis and management of immune-related pulmonary toxicity; or patients with CT image indicating active pneumonia or severely impaired pulmonary function during screening. Radiation pneumonia is acceptable in the radiation field. Patients with active tuberculosis will be excluded;
  • Active autoimmune disease or history of autoimmune disease with recurrence potential (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis): Patients with skin diseases that do not require systemic treatment such as vitiligo, psoriasis, hair loss, controlled type I diabetes receiving insulin therapy; childhood asthma that is completely relieved, or those who do not need any intervention in adulthood can be included; Patients with asthma who undergo medical intervention such as bronchiectasis, cannot be included;
  • Use immunosuppressive agents or systemic hormone therapy within preceding 14 days before the study starts to achieve the purpose of immunosuppression (dose>10mg/day prednisone or hormones with equivalent effects);
  • Patients who received strong CYP3A4/CYP2C19 inducer including rifampin (and its analogs) and hypericum perforatum or strong CYP3A4/CYP2C19 inhibitor within preceding 14 days;
  • Patients who have a history of severe allergies to any monoclonal antibody or anti-angiogenic targeted drugs;
  • Patients who have severe uncontrolled infection during study screening;
  • Patients who are pregnant or lactating;
  • Patients who refuse to receive tumor biopsy during rule-in and rule-out period;
  • Other reasons according to the investigator's judgement.

Trial locations and contacts

1 site in 1 country.

Yu-Long Wang, MD contact

+86-18017317225

yulongwang@fudan.edu.cn

Qing-Hai Ji, MD contact

headneck@126.com

China1 site

  • 270 Dongan Road, Fudan University Shanghai Cancer Center

    Shanghai, 200032

    Yu-Long Wang, +86-18017317225, yulongwang@fudan.edu.cn

    Qing-Hai Ji, headneck@126.com

Other trials in China

About this study

Official title: The Efficacy and Safety of Anti-PD-1 Antibody Toripalimab Combined With Surufatinib for Locally Advanced Thyroid Cancer: a Phase II Study

This study is designed to evaluate the efficacy and safety of the combination of Toripalimab and Surufatinib for Locally Advanced Thyroid Cancer.

Read the detailed description

Surufatinib (HMPL-012, previously named sulfatinib) is a small-molecule inhibitor targeting vascular endothelial growth factor receptors, fibroblast growth factor receptor 1 and colony-stimulating factor 1 receptor. A multi-center , opened, Phase II study have identified the efficacy and safety of Surufatinib in advanced medullary thyroid Carcinoma ( MTC) and iodine-refractory differentiated thyroid carcinoma (DTC).Toripalimab is a humanized immunoglobulin (Ig) G4 monoclonal antibody directed against the negative immunoregulatory human cell surface receptor programmed cell death 1 (programmed death-1; PD-1), with potential immune checkpoint inhibitory and antineoplastic activities. In the present study, we design a single-arm, single center Phase II trial to evaluate the efficacy and safety of the combination of Surufatinib wiht Toripalimab in locally advanced differentiated thyroid cancer as neoadjuvant therapy.

Conditions
Thyroid Cancer
Being tested
Surufatinib, Toripalimab
Keywords
Toripalimab, Surufatinib, Thyroid cancer, Neoadjuvant therapy
Medical subject headings
Thyroid Neoplasms

What participants receive

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

  • SurufatinibDrug

    Also called HMPL-012

    Surufatinib is a tablet in the form of 50mg, oral, once a day.

  • ToripalimabDrug

    Also called JS001

    Toripalimab is an injection in the form of 240mg, intravenous, once three weeks.

Study groups in NCT04524884
Study groupRoleWhat they receive
Cohort AExperimentalSurufatinib 250mg will be taken orally once daily continuously through a 21-day cycle of study treatment. Toripalimab 240mg will be intravenously administered on Day 1 of each cycle. After neoadjuvant Toripalimab and Surufatinib treatment, the patients will receive operation treatment if the tumor is evaluated as resectable cases by clinical examination.
Receives: Drug: Surufatinib; Drug: Toripalimab
Cohort BExperimentalSurufatinib 250mg will be taken orally once daily continuously through a 21-day cycle of study treatment. Toripalimab 240mg will be intravenously administered on Day 1 of each cycle. After neoadjuvant Toripalimab and Surufatinib treatment, the patients will receive further drug reatment, if the tumor is evaluated as unresectable cases and patients have potential benefits by clinical examination.
Receives: Drug: Surufatinib; Drug: Toripalimab
Cohort CExperimentalSurufatinib 250mg will be taken orally once daily continuously through a 21-day cycle of study treatment. Toripalimab 240mg will be intravenously administered on Day 1 of each cycle. After neoadjuvant Toripalimab and Surufatinib treatment, the patients will be removed from the study, if the tumor is evaluated as unresectable cases and patients have no potential benefits by clinical examination.
Receives: Drug: Surufatinib; Drug: Toripalimab

What is being measured

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

  1. ORR

    Objective Response Rate

    Measured: 16 months after the last patient enrolled

Secondary outcomes (6)

  1. R0/1 resection rate

    R0 and R1 resection rate reviewed by operation team and pathologists

    Measured: Within one week after operation

  2. DCR

    Disease Control Rate

    Measured: 16 months after the last patient enrolled

  3. TTR

    Time to objective response

    Measured: 16 months after the last patient enrolled

  4. PFS

    Progression Free Survival

    Measured: 16 months after the last patient enrolled

  5. OS

    Overall Survival

    Measured: 16 months after the last patient enrolled

  6. AE

    adverse events

    Measured: From first dose to within 30 days after the last dose

Timeline

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

  1. First posted24 Aug 2020
  2. Study start1 Oct 2020 (estimated)
  3. Primary completion30 Apr 2022 (estimated)
  4. Study completion30 Sep 2022 (estimated)

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
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04524884
Sponsor's protocol ID
Thca-NEO-ST
Status last verified
Aug 2020
First submitted
20 Aug 2020
Last updated
24 Aug 2020
Results posted
No
Data monitoring committee
Yes
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 study testing Surufatinib and Toripalimab in people with Thyroid Cancer, run by Fudan University at 1 site 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 11 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 24 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 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.

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

Are results available for this study?

Results are not available in the source record.

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

Contact Yu-Long Wang, MD (+86-18017317225, yulongwang@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (time frame: 16 months after the last patient enrolled). 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 NCT04524884.

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 24 Aug 2020.

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