Famitinib in Combination With Adebrelimab for the Treatment of Advanced Thyroid Cancer
NCT ID: NCT06146985
Last Updated: 2023-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
67 participants
INTERVENTIONAL
2023-12-01
2025-05-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Differentiated Thyroid Cancer refractory to standard treatment（DTC）
Participants 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.
20 mg Famitinib & 1200 mg Adebrelimab
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
Medullary Thyroid Cancer(MTC)
Participants 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.
20 mg Famitinib & 1200 mg Adebrelimab
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
Anaplastic Thyroid Carcinoma（ATC）
Participants 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.
20 mg Famitinib & 1200 mg Adebrelimab
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
Interventions
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20 mg Famitinib & 1200 mg Adebrelimab
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
Eligibility Criteria
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Inclusion Criteria
(4)DTC has progressed after I-131 or thyroid hormone-treating (match any one of the following conditions):
1. At least one measurable lesion loses the ability of Iodine uptake after Iodine radiation treatment.
2. Disease progression occurs for at least one measurable lesion within 12 months after I-131 treatment, even with the ability of Iodine uptake.
3. 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.
(8)ECOG score between 0 to 1. (9)Laboratory examination confirms that the organ functions are enough within 14 days before the first dose:
1. Blood test: WBC≥3.0×109/L；ANC≥1.5×109/L；PLT≥50×109/L；HGB≥90 g/L
2. Liver function: AST≤3.0×ULN；ALT≤3.0×ULN；TBIL\<60 μmol/L;
3. Kidney function: Cr≤1.5×ULN or CrCl ≥30 mL/min;
4. Coagulation function: INR≤1.5，APTT≤1.5 ×ULN
5. 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.
Exclusion Criteria
2. Has been treated by immunotherapy, such as PD-1 antibody, PD-L1 antibody, and CTLA-4 antibody.
3. 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).
(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:
1. Those who have active peptic ulcer lesions and positive fecal occult blood;
2. 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.
18 Years
75 Years
ALL
Yes
Sponsors
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Ruijin Hospital
OTHER
Responsible Party
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QIU WEIHUA
Director
Central Contacts
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Other Identifiers
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TC-IIT-FMTN-SHR-1316
Identifier Type: -
Identifier Source: org_study_id