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Thyroid CancerPhase 2NCT06787911

Donafenib Combined With Anti-PD-1 Antibody for Neoadjuvant Therapy in Locally Advanced Thyroid Cancer

A Phase 2 study testing Donafeib with Sintilimab in people with Thyroid Cancer, run by Yu Wang at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This study is a single-arm intervention study. Locally advanced differentiated thyroid carcinoma patients receive neoadjuvant therapy with Donafenib and PD-1 antibody Sintilimab and those who can undergo surgery after neoadjuvant therapy receive surgical treatment. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Thyroid Cancer
What is being tested?
Donafeib with Sintilimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteChina
Study dates
24 Jul 2024to 30 Sep 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntarily enroll and sign a written informed consent form;
  • Age>=18 years old,<=80 years old, regardless of gender;
  • Locally advanced differentiated thyroid carcinoma (DTC) diagnosed by pathological histology;
  • Locally advanced DTC is defined as meeting at least one of the criteria: surgery is expected to be difficult to complete R0/R1 resection; AJCC defined T4 stage: any size of tumor infiltrating beyond the thyroid capsule to the subcutaneous soft tissue, throat, trachea, esophagus, recurrent laryngeal nerve, tumor invades the prevertebral fascia or surrounds the carotid or mediastinal vessels.
  • Voluntarily undergo tumor biopsy/operation at enrollment and exit.
  • Have not received any anti-tumor treatment in the past;
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  • According to the evaluation criteria for the efficacy of solid tumors (RECIST version 1.1), there should be at least one imaging measurable lesion. Lesions located within the radiation field of previous radiotherapy can be considered measurable if confirmed to have progressed;
  • The physical condition (PS) score of the Eastern Cancer Collaborative Group (ECOG) is 0-2 points;
  • Expected survival time>3 months;
  • Female patients with fertility (referring to those who have not undergone menopause or surgical sterilization) must have a negative serum pregnancy test result within 7 days before the study drug administration;
  • Female or male patients with fertility must take reliable contraceptive measures during the study drug use period and within 60 days after the last medication use;
  • Normal function of major organs, i.e. meeting the following criteria: Blood routine examination (no blood transfusion or G-CSF used within 14 days prior to screening): a) Hemoglobin>=90 g/L; b) Absolute neutrophil count (ANC)>=1.5 × 109/L; c) Platelet count>=80 × 109/L; Blood biochemistry test (no albumin used within 14 days prior to screening): d) Total bilirubin<=1.5 x Upper limit of normal value (ULN); e) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)<=2.5 x ULN (ALT or AST<=5 x ULN allowed for subjects with liver metastasis); f) Creatinine<=1.5 x ULN; Coagulation function: g) International standardized ratio (INR) or prothrombin time (PT)<=1.5 x ULN; h) Activated partial thromboplastin time (APTT)<=1.5 x ULN; Others: i) Urinary protein<2+(if urinary protein>=2+, 24-hour urine protein quantification can be performed, and 24-hour urine protein quantification<1.0g can be included in the group).j)Myocardial enzyme profiles were within the normal range (simple laboratory abnormalities not clinically significant were also allowed to be included)

Who cannot join

  • Other histological subtypes of thyroid cancer (such as undifferentiated carcinoma, myeloid carcinoma, lymphoma, or sarcoma) that are not associated with DTC;
  • Patients who undergo thyroid cancer radical surgery again;
  • Central nervous system metastasis and/or cancerous meningitis with clinical symptoms, and a history of leptomeningeal carcinoma;
  • Within the first 5 years of randomization, cancer with a different primary site or histological type from thyroid cancer, or cancer coexisting with thyroid cancer but with a different primary site or histological type, except for cervical carcinoma in situ, treated basal cell carcinoma, and superficial bladder tumors (non-invasive tumors, carcinoma in situ, and tumor invasion of the lamina propria);
  • Previous or current congenital or acquired immunodeficiency disease;
  • Active or previously documented autoimmune disease or inflammatory disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, inflammatory bowel disease, systemic lupus erythematosus, vasculitis, uveitis, Hypophysitis, hyperthyroidism or hypothyroidism, asthma requiring bronchodilator treatment, etc.), patients with vitiligo or asthma that has been completely resolved in childhood, without any intervention in adulthood can be included;
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  • Have a history of severe mental illness in the past;
  • Suffering from diseases that affect the absorption, distribution, metabolism, or clearance of investigational drugs (such as severe vomiting, chronic diarrhea, intestinal obstruction, absorption disorders, etc.); Previous or concomitant medication/treatment:
  • Has undergone major surgery (as defined by the researcher) within 4 weeks prior to enrollment, or is expected to require major surgery during the study treatment period;
  • Have received iodine-131 ablation or other local anti-tumor treatments within the past 3 months, or plan to undergo systemic anti-tumor treatment or external irradiation or other interventional treatments during the medication period of this study, including cytotoxic therapy, signal transduction inhibitors, immunotherapy (or have used mitomycin C within 6 weeks before receiving the investigational drug treatment). The use of levothyroxine for TSH inhibition and thyroid hormone supplementation therapy is not prohibited;
  • Previously received organ or allogenic bone marrow transplantation;
  • Previously received targeted therapy drugs targeting VEGF, including but not limited to anlotinib, apatinib, bevacizumab, etc;
  • Previously received immune therapy drugs including but not limited to anti CTLA-4, anti PD-1, anti PD-L1, anti PD-L2, anti CD137. Therapeutic anti-tumor vaccines are not included;
  • Systemic immunosuppressive drug treatment has been used within 2 weeks before enrollment, or systemic immunosuppressive drug treatment is expected to be required during the study period, except for the following cases:
  • Intranasal, inhaled, topical or local injection (such as intra-articular injection) corticosteroids;
  • The dose does not exceed 10 mg/day of prednisone or other equivalent systemic corticosteroids;
  • Prophylactic use of corticosteroids for hypersensitivity reactions;
  • Simultaneously taking drugs that may prolong QTc and/or induce apical torsion transition ventricular tachycardia (Tdp) or affect drug metabolism;
  • Security:
  • The patient has a known or suspected history of allergies to donafinib or similar drugs, or a history of hypersensitivity to chimeric or humanized antibodies or fusion proteins, or allergies to excipients of the study drug;
  • Imaging shows that the tumor has invaded important blood vessels, or the investigator determines that the patient's tumor is highly likely to invade important blood vessels during treatment and cause fatal bleeding;
  • Active bleeding or abnormal coagulation function, with a tendency to bleed or undergoing thrombolysis, anticoagulation, or antiplatelet therapy;
  • Have a history of gastrointestinal bleeding within the past 4 weeks or have a clear tendency for gastrointestinal bleeding (such as known local active ulcer lesions, fecal occult blood++, if continuous fecal occult blood++, gastroscopy should be performed), or other conditions determined by the researcher that may cause gastrointestinal bleeding (such as severe gastric fundus/esophageal varices);
  • Have experienced gastrointestinal perforation, abdominal fistula, or abdominal abscess within the past 6 months;
  • Have experienced thrombosis or thromboembolic events within the past 6 months, such as stroke and/or transient ischemic attack, deep vein thrombosis, pulmonary embolism, etc;
  • Cardiovascular diseases with significant clinical significance, including but not limited to acute myocardial infarction, severe/unstable angina, or coronary artery bypass grafting surgery within the past 6 months, congestive heart failure (New York Heart Association NYHA grade>2), poorly controlled or requiring pacemaker treatment for arrhythmia, and uncontrolled hypertension (systolic blood pressure>=140 mmHg and/or diastolic blood pressure>=90 mmHg);
  • Active infections, including: a) AIDS virus (HIV/2 antibody) positive; b) Active hepatitis B (HBsAg positive and abnormal liver function); c) Active hepatitis C (HCV antibody positive or HCV RNA ≥ 103 copies/ml with abnormal liver function); d) Active tuberculosis; e) Other uncontrollable active infections (CTCAE V5.0>level 2);
  • Other significant clinical and laboratory abnormalities, which the researchers believe affect the safety evaluation, such as uncontrollable diabetes, chronic kidney disease, peripheral neuropathy of grade II or above (CTCAE V5.0), thyroid dysfunction, etc;
  • Has not yet recovered from surgery, such as the presence of unhealed incisions or serious postoperative complications;
  • Within 4 weeks prior to enrollment or possibly during the study period, receive any attenuated live vaccines;
  • Pregnant or lactating women, as well as female or male patients with fertility who are unwilling or unable to take effective contraceptive measures;
  • Other:
  • Have a history of alcohol, psychotropic drugs, or other substance abuse within the past 6 months;
  • Have received clinical trials of other drugs or medical devices within 4 weeks prior to enrollment. TSH inhibition therapy is not prohibited;
  • Unable to follow the research protocol for treatment or follow up on schedule;
  • Any other researcher deemed ineligible for enrollment.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yu Wang contact

+86 21 6417 5590

neck130@sina.com

China1 site, 1 recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032

    Wanlin Liu, +86 21 6417 5590, liuwanlin9339@163.com

    Recruiting

Other trials in China

About this study

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

This study is a single-arm intervention study. Locally advanced differentiated thyroid carcinoma patients receive neoadjuvant therapy with Donafenib and PD-1 antibody Sintilimab and those who can undergo surgery after neoadjuvant therapy receive surgical treatment. The aim of the study is to evaluate the efficacy and safety of Donafenib combined with PD-1 antibody in neoadjuvant therapy of locally advanced thyroid cancer.

Conditions
Thyroid Cancer
Being tested
Donafeib with Sintilimab
Medical subject headings
Thyroid Neoplasms

What participants receive

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

  • Donafeib with SintilimabDrug

    Patients receive Donafenib and PD-1 antibody Sintilimab

Study groups in NCT06787911
Study groupRoleWhat they receive
Treatment groupExperimentalPatients receive Donafenib and PD-1 antibody Sintilimab
Receives: Drug: Donafeib with Sintilimab

What is being measured

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

  1. Objective response rate

    The proportion of patients with complete response (CR) and partial response (PR) to the total number of evaluable cases.

    Measured: From enrollment to the end of treatment at 4 weeks

Secondary outcomes (6)

  1. R0/R1 resection rate

    The rate of patients who receive R0 or R1 resection surgery after neoadjuvant treatment in all patients undergo surgery.

    Measured: From enrollment to the end of treatment at 4 weeks

  2. Progression free survival

    The time from surgery to tumor progression, including local-regional recurrence and distant metastasis

    Measured: 5 years after surgery

  3. Tumor recurrence time

    Time from treatment to the first date received CR or PR status

    Measured: 5 years after surgery

  4. disease control rate

    The percentage of patients who received CR、PR or SD status of all patients enrolled

    Measured: 5 years after surgery

  5. 3-year local recurrence-free survival

    3-year local recurrence-free survival

    Measured: From enrollment to the end of treatment at 3 years

  6. 5-year local recurrence-free survival

    5-year local recurrence-free survival

    Measured: From enrollment to the end of treatment at 5 years

Timeline

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

  1. First posted22 Jan 2025
  2. Study start24 Jul 2024
  3. Primary completion31 May 2025 (estimated)
  4. Study completion30 Sep 2026 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
14 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06787911
Sponsor's protocol ID
DPM-DTC
Status last verified
Jan 2025
First submitted
30 Nov 2024
Last updated
22 Jan 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Donafeib with Sintilimab in people with Thyroid Cancer, run by Yu Wang 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 12 inclusion and 36 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: looking for participants now, as of the sponsor's last update on 22 Jan 2025. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Yu Wang (+86 21 6417 5590, neck130@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (time frame: From enrollment to the end of treatment at 4 weeks). 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 NCT06787911.

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 22 Jan 2025.

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