Thyroid CancerPhase 2NCT04612894
Camrelizumab and Apatinib for Neoadjuvant Therapy in Thyroid Cancer
A Phase 2 study testing Camrelizumab and Apatinib, surgery and core needle biopsy in people with Thyroid Cancer, run by Fudan University at 1 site in China.
Trial summary
To determine the efficacy and safety of anti-PD-1 antibody Camrelizumab combined with Apatinib for neoadjuvant therapy in locally advanced thyroid cancer. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Thyroid Cancer
- What is being tested?
- Camrelizumab and Apatinib, surgery and core needle biopsy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2020to 31 Dec 2023
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Shanghai Cancer Center
Shanghai, 200032
Yu Wang, M.D., 86-021-64175590 ext. 65805, neck130@hotmail.com
About this study
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
To determine the efficacy and safety of anti-PD-1 antibody Camrelizumab combined with Apatinib for neoadjuvant therapy in locally advanced thyroid cancer.
- Conditions
- Thyroid Cancer
- Being tested
- Camrelizumab and Apatinib, surgery, core needle biopsy
- Keywords
- thyroid cancer, locally advanced, neoadjuvant, Camrelizumab, Apatinib
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Camrelizumab and ApatinibDrug
All patients will receive Camrelizumab and Apatinib for at least two cycles of neoadjuvant treatment
surgeryProcedure or surgery
Perform surgery if operable after neoadjuvant therapy
core needle biopsyProcedure or surgery
Perform core needle biopsy if inoperable after neoadjuvant therapy
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant Camrelizumab + Apatinib | Experimental | Apatinib 250mg, po qd, and Camrelizumab 200mg, iv q2w as neoadjuvant treatment. 28 days as one cycle, for at least two cycles. Receives: Drug: Camrelizumab and Apatinib; Procedure: surgery; Procedure: core needle biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
ORR
Measured: up to 24 weeks
Secondary outcomes (4)
R0/1 resection rate
R0/1 resection rate if operable
Measured: at the time of surgery
Disease control rate
DCR
Measured: at the time point of 6 weeks
Overall survival
OS
Measured: up to 3 years
Adverse Events
AEs
Measured: from the first drug administration to within 90 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start1 Dec 2020 (estimated)
- Primary completion1 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04612894
- Sponsor's protocol ID
- CALA-TC
- Status last verified
- Oct 2020
- First submitted
- 30 Oct 2020
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04612894
- Acronym / sponsor ID
- CALA-TC
- Conditions
- Thyroid Cancer
- Keywords
- thyroid cancer, locally advanced, neoadjuvant, Camrelizumab, Apatinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 3 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the efficacy and safety of anti-PD-1 antibody Camrelizumab combined with Apatinib for neoadjuvant therapy in locally advanced thyroid cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant Camrelizumab + Apatinib | Experimental | Drug: Camrelizumab and Apatinib, Procedure: surgery, Procedure: core needle biopsyApatinib 250mg, po qd, and Camrelizumab 200mg, iv q2w as neoadjuvant treatment. 28 days as one cycle, for at least two cycles. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Camrelizumab and ApatinibAll patients will receive Camrelizumab and Apatinib for at least two cycles of neoadjuvant treatment | Drug | Neoadjuvant Camrelizumab + Apatinib |
| surgeryPerform surgery if operable after neoadjuvant therapy | Procedure or surgery | Neoadjuvant Camrelizumab + Apatinib |
| core needle biopsyPerform core needle biopsy if inoperable after neoadjuvant therapy | Procedure or surgery | Neoadjuvant Camrelizumab + Apatinib |
Primary outcome
Objective response rate
Time frame: up to 24 weeks
ORR
4 secondary outcomes
R0/1 resection rate
Time frame: at the time of surgery
Disease control rate
Time frame: at the time point of 6 weeks
Overall survival
Time frame: up to 3 years
Adverse Events
Time frame: from the first drug administration to within 90 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Camrelizumab and Apatinib, surgery and core needle biopsy in people with Thyroid Cancer, run by Fudan University 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 7 inclusion and 8 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 3 Nov 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu Wang, M.D. (86-021-64175590 ext. 65805, neck130@hotmail.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: up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Nov 2020.