Camrelizumab and Apatinib for Neoadjuvant Therapy in Thyroid Cancer
NCT ID: NCT04612894
Last Updated: 2020-11-03
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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UNKNOWN
PHASE2
31 participants
INTERVENTIONAL
2020-12-01
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Neoadjuvant Camrelizumab + Apatinib
Apatinib 250mg, po qd, and Camrelizumab 200mg, iv q2w as neoadjuvant treatment. 28 days as one cycle, for at least two cycles.
Camrelizumab and Apatinib
All patients will receive Camrelizumab and Apatinib for at least two cycles of neoadjuvant treatment
surgery
Perform surgery if operable after neoadjuvant therapy
core needle biopsy
Perform core needle biopsy if inoperable after neoadjuvant therapy
Interventions
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Camrelizumab and Apatinib
All patients will receive Camrelizumab and Apatinib for at least two cycles of neoadjuvant treatment
surgery
Perform surgery if operable after neoadjuvant therapy
core needle biopsy
Perform core needle biopsy if inoperable after neoadjuvant therapy
Eligibility Criteria
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Inclusion Criteria
* Pathologically diagnosed locally advanced thyroid cancer, including papillary thyroid cancer, medullary cancer, follicular cancer, poorly differentiated cancer, etc., require surgical resection with or without distant metastasis;
* Preoperative assessment of locally advanced thyroid cancer (unable to achieve R0/1 resection or T4 disease);
* Have at least one measurable lesion (RECIST 1.1);
* Age\>=14 years, Eastern Cooperative Oncology Group (ECOG) score 0-1;
* Patient agree to receive surgery/ core needle biopsy before and after neoadjuvant treatment.
* The main organ functions meet the criteria before treatment.
Exclusion Criteria
* Received external radiation therapy or iodine-131 therapy within the past 28 days; or planned systemic anti-tumor therapy during this study;
* Pathologically confirmed non-thyroid epithelial cell-derived malignant tumors (including lymphoma, metastatic cancer, sarcoma, etc.);
* With other uncontrolled / under treatment malignancies;
* Those who have multiple factors (such as inability to swallow) that affect oral medication;
* Patients with any severe and / or uncontrolled illness,
* 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;
* According to the investigator's judgment, there are concomitant diseases that seriously endanger the safety of patients or affect patients to complete the research.
14 Years
ALL
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Locations
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Fudan University Shanghai Cancer Center
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CALA-TC
Identifier Type: -
Identifier Source: org_study_id