Clinical trial NCT04612894: Camrelizumab and Apatinib for Neoadjuvant Therapy in Thyroid Cancer
Official title: The Efficacy and Safety of Anti-PD-1 Antibody Camrelizumab Combined With Apatinib for Neoadjuvant Therapy in Locally Advanced Thyroid Cancer: a Phase II Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Thyroid Cancer
Keywords: thyroid cancer
locally advanced
neoadjuvant
Camrelizumab
Apatinib
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2020-11-03
Enrollment: 31
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine the efficacy and safety of anti-PD-1 antibody Camrelizumab combined with Apatinib for neoadjuvant therapy in locally advanced thyroid cancer.


Eligibility criteria: Inclusion Criteria:

* The patient volunteered to participate in the study and signed an informed consent form;
* 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:

* Patients who have previously been treated with immune checkpoint inhibitors (including but not limited to nivolizumab, pembrolizumab, teriplizumab, sintilizumab, etc.);
* 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.

Primary outcomes:
measure: Objective response rate
timeFrame: up to 24 weeks
Secondary outcomes:
measure: R0/1 resection rate
timeFrame: at the time of surgery
measure: Disease control rate
timeFrame: at the time point of 6 weeks
measure: Overall survival
timeFrame: up to 3 years
measure: Adverse Events
timeFrame: from the first drug administration to within 90 days after surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
Study officials:
References: