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Thyroid CancerPhase 2NCT06146985

Famitinib in Combination With Adebrelimab for the Treatment of Advanced Thyroid Cancer

A Phase 2 study testing 20 mg Famitinib & 1200 mg Adebrelimab in people with Thyroid Cancer, run by Ruijin Hospital.

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 The sponsor has not verified this record for over two years, so it may be out of date.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 is a multi-cohort, open-label, single-centre, Phase 2 study aiming to investigate the efficacy and safety of a regimen using the multi-targeted kinase inhibitor Famitinib in combination with the PD-L1 antibody Adebrelimab for the patients with unresectable locally advanced or metastatic refractory to standard… Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Thyroid Cancer
What is being tested?
20 mg Famitinib & 1200 mg Adebrelimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
67 participants
Where
No sites listed yet
Study dates
1 Dec 2023to 1 May 2025
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 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • (1)Sign on the informed consent form. (2)Age between 18 to 75 years old. (3)Histologically or cytologically confirmed unresectable locally advanced or metastatic Differentiated Thyroid Cancer (DTC), locally advanced or metastatic Medullary thyroid cancer (MTC), and Anaplastic Thyroid Cancer (ATC).
  • (4)DTC has progressed after I-131 or thyroid hormone-treating (match any one of the following conditions):
  • At least one measurable lesion loses the ability of Iodine uptake after Iodine radiation treatment.
  • Disease progression occurs for at least one measurable lesion within 12 months after I-131 treatment, even with the ability of Iodine uptake.
  • Cumulative dose of Iodine treatment ≥ 22.2 (GBq); the final treatment should be six months before enrollment. As for the patients who do not belong to the poorly differentiated subtype, their TSH level should be at the inhibitory level from the Screening phase.
  • (5)Resistance of Lenvatinib and Anlotinib. (6)BRAF V600E, RET mutation does not exist. (7)At least one measurable lesion. According to the RECIST v1.1, the long diameter through Spiral CT scanning should be no less than 10 mm, or the short diameter of the lymphoid should be no less than 15 mm; the confirmed progressed lesion received local treatment can be regarded as a targeted lesion.
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  • (8)ECOG score between 0 to 1. (9)Laboratory examination confirms that the organ functions are enough within 14 days before the first dose:
  • Blood test: WBC≥3.0×109/L；ANC≥1.5×109/L；PLT≥50×109/L；HGB≥90 g/L
  • Liver function: AST≤3.0×ULN；ALT≤3.0×ULN；TBIL<60 μmol/L;
  • Kidney function: Cr≤1.5×ULN or CrCl ≥30 mL/min;
  • Coagulation function: INR≤1.5，APTT≤1.5 ×ULN
  • HBV-DNA≤2×103IU/ml (The participants whose HBV-DNA> 2×103IU/ml should taking anti-virus treatment after enrollment).
  • (10)Male participants, as well as females of childbearing age, must take contraceptive measures from the start of the first dose to 3 months after the final dose.

Who cannot join

  • Previous or simultaneous concomitant with other malignant tumors (except treated non-malignant melanoma skin cancer, cervical carcinoma in situ, papillary thyroid cancer).
  • Has been treated by immunotherapy, such as PD-1 antibody, PD-L1 antibody, and CTLA-4 antibody.
  • With the cardiac clinical symptoms or diseases which cannot be controlled well, such as:
  • 1) Class 2 and upper classes of cardiac insufficiency (according to NYHA), or cardiac color ultrasound examination confirms LVEF < 50 %.
  • 2) Unstable Angina Pectoris. 3) Myocardial infarction occurs in one year before research. 4) Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention.
  • 5) Female: QTc>470ms; Male: QTc>450ms. (Calculated by Fridericia formula; average value of 3 tests can be used if QTc shows abnormal results every 2 min).
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  • (4)Previous hypertensive crisis or hypertensive encephalopathy or high blood pressure which cannot be reduced to normal range by antihypertensive medication (systolic blood pressure≥140mmHg or diastolic blood pressure ≥90mmHg). Taking antihypertensive medication is acceptable to achieve the upper parameter.
  • (5)Have multiple factors affect oral absorption, such as inability to swallow, nausea and vomiting, chronic diarrhea, and intestinal obstruction.
  • (6)Have risks of gastrointestinal bleeding including:
  • Those who have active peptic ulcer lesions and positive fecal occult blood;
  • Those with a history of melena and hematemesis within 3 months. (7)Abnormal coagulation function (INR>1.5×ULN、APTT>1.5×ULN) or the ones who have the trend of bleeding.
  • (8)Have a history of organ transplantation or hepatic encephalopathy. (9)Have immunodeficiency disease within 7 days before the first dose, or are receiving systemic hormone therapy (≥10 mg/day prednisone or other hormones at equal doses), or other forms of immunosuppressive therapy.
  • (10)Severe allergic reaction for Iodinated contrast media, antibody drugs, and anti-angiogenic drugs. (≥ Class 3) (11)Have taken part in other clinical trials or taken other experimental drug within 4 weeks before the first dose.
  • (12)A positive pregnancy test at baseline in a pregnant or breastfeeding woman or a woman of childbearing age.
  • (13)Other factors that may affect subject safety or trial compliance as judged by the researcher.

Trial locations and contacts

No sites are listed yet.

Weihua Qiu, M.D. contact

0086-021-64370045

drqwh2003@126.com

About this study

Official title: A Multicohort, Single-Centre, Phase II Trial of the Efficacy and Safety of Famitinib in Combination With Adebrelimab for the Treatment of Advanced Thyroid Cancer

This is a multi-cohort, open-label, single-centre, Phase 2 study aiming to investigate the efficacy and safety of a regimen using the multi-targeted kinase inhibitor Famitinib in combination with the PD-L1 antibody Adebrelimab for the patients with unresectable locally advanced or metastatic refractory to standard treatment differentiated thyroid cancer (DTC), medullary thyroid carcinoma (MTC) as well as Anaplastic thyroid carcinoma (ATC).

Read the detailed description

The participants who meet the inclusion criteria will be assigned to different cohorts to be treated. Participants will receive Adebrelimab 1200 mg intravenously once every three weeks (Q3W), together with Famitinib 20 mg orally daily before or after the diet. Participants will be given the regimen of Famitinib in combination with Adebrelimab during the Treatment phase until disease progression or undulated toxicity appears.

Conditions
Thyroid Cancer
Being tested
20 mg Famitinib & 1200 mg Adebrelimab
Medical subject headings
Thyroid Neoplasms

What participants receive

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

  • 20 mg Famitinib & 1200 mg AdebrelimabCombination product

    Famitinib is a novel multi-targeted tyrosine kinase inhibitor targeting VEGFR2, PDGFR, and c-kit. Adebrelizumab is a humanised immunoglobulin G4 (IgG4) monoclonal antibody that binds specifically to human PD-L1

Study groups in NCT06146985
Study groupRoleWhat they receive
Differentiated Thyroid Cancer refractory to standard treatment（DTC）ExperimentalParticipants will receive 1200mg Adebrelimab i.v. once every 3 weeks and 20 mg Famitinib orally before or after the meal every day for 3 weeks until PD and/or endurable toxicity appears.
Receives: Combination Product: 20 mg Famitinib & 1200 mg Adebrelimab
Medullary Thyroid Cancer(MTC)ExperimentalParticipants will receive 1200mg Adebrelimab i.v. once every 3 weeks and 20 mg Famitinib orally before or after the meal every day for 3 weeks until PD and/or endurable toxicity appears.
Receives: Combination Product: 20 mg Famitinib & 1200 mg Adebrelimab
Anaplastic Thyroid Carcinoma（ATC）ExperimentalParticipants will receive 1200mg Adebrelimab i.v. once every 3 weeks and 20 mg Famitinib orally before or after the meal every day for 3 weeks until PD and/or endurable toxicity appears.
Receives: Combination Product: 20 mg Famitinib & 1200 mg Adebrelimab

What is being measured

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

  1. Objective Response Rate (ORR)

    ORR was defined as the percentage of participants with the best overall response (BOR) of complete response (CR) or partial response (PR) as measured by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).

    Measured: From date of treatment start until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months

Secondary outcomes (4)

  1. Disease control rate (DCR)

    DCR is defined as the proportion of participants with complete response (CR), partial response (PR) and stable disease (SD) as measured by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).

    Measured: From date of treatment start until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months

  2. Progression-free survival (PFS)

    PFS is defined as the time from the date of randomisation to the date of first documentation of PD or date of death, whichever occurs first, as measured by RECIST V1.1.

    Measured: From date of treatment start until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months

  3. Overall Survival (OS)

    OS is defined as the time from treatment to death, regardless of disease recurrence.

    Measured: From date of treatment start until the date of death from any cause, assessed up to 60 months

  4. Safety Assessment

    The safety assessment includes the rate of treatment-related adverse effects, severe adverse effects, and abnormal laboratory examination results, which have clinical significance according to CTCAE v 5.0.

    Measured: From treating to the date AEs, SAEs, or abnormal results occurs. assessed up to 60 months

Timeline

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

  1. First posted27 Nov 2023
  2. Study start1 Dec 2023 (estimated)
  3. Primary completion15 Nov 2024 (estimated)
  4. Study completion1 May 2025 (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
Parallel groups
Masking
None (open label)
Enrolment
67 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06146985
Sponsor's protocol ID
TC-IIT-FMTN-SHR-1316
Status last verified
Nov 2023
First submitted
8 Nov 2023
Last updated
28 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 20 mg Famitinib & 1200 mg Adebrelimab in people with Thyroid Cancer, run by Ruijin Hospital.

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 13 inclusion and 15 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 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

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 Weihua Qiu, M.D. (0086-021-64370045, drqwh2003@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: From date of treatment start until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months). 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 NCT06146985.

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 28 Nov 2023.

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