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Camrelizumab in Combination With Apatinib in Patients With Radioactive Iodine-refractory Differentiated Thyroid Cancer

Primary Purpose

Radioactive Iodine-refractory Differentiated Thyroid Cancer

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Camrelizumab combination with Apatinib
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Radioactive Iodine-refractory Differentiated Thyroid Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

1. Aged after 18 years (18 is included). 2. Locally advanced or metastatic differentiated thyroid cancer (papillary, follicular, Hurthle cells, poorly differentiated carcinoma). At least one measurable lesion (helical CT scan long diameter ≥10mm, meet the requirements of the standard Response Evaluation Criteria In Solid Tumors(RESCIST) version 1.1).

3. ECOG-PS score 0-2 4. Life Expectancy of at least 12 weeks 5. Subjects must be 131I-refractory / resistant as defined by at least one of the following.

  1. Lesions that do not demonstrate iodine uptake on any radioiodine scan.
  2. Subjects received a single radioactive iodine therapy within 12 months (≥ 3.7 Giga Bequerel(GBq)[≥ 100 millicurie(mCi)]) and target lesion disease progression.
  3. Every two radioactive iodine treatment interval <12 months, doses ≥ 3.7 GBq [≥100mCi], disease progress more than 12 months after at least once iodine therapy.
  4. Received a total dose of radioactive iodine therapy ≥ 22.2 GBq (≥ 600 mCi). 6. Have the required screening laboratory values.

Exclusion Criteria:

  1. Other thyroid cancer histological subtypes (such as medullary carcinoma, lymphoma or sarcoma).
  2. Any active autoimmune disease or history of autoimmune disease and expected recurrence (including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis); subjects with skin diseases that does no need systemic treatment, for example, leukoderma, psoriasis, alopecia, those with controlled type I diabetes by insulin or those with asthma that has been completely resolved in childhood and with no need of any intervention can be enrolled; while subjects with asthma who need bronchodilator for medical intervention cannot be enrolled.
  3. Use of strong CYP3A4/CYP2C19 inducers, including rifampicin (and its analogues) and St. John's Wort, or strong CYP3A4/CYP2C19 inhibitors within two weeks prior to signing informed consent form.
  4. Previous treatment with other immune checkpoint inhibitors (include PD-1 antibody or other immunotherapy against PD-1/PD-L1).
  5. Known history of serious allergy to any monoclonal antibody or Apatinib.
  6. Inability or unwilling to swallow tablets, malabsorption syndrome or any condition affecting gastrointestinal absorption.
  7. Previous or current presence of metastasis to central nervous system.
  8. Severe infection within 4 weeks prior to the start of study treatment, including but not limited to hospitalization for infection, bacteremia or complications of severe pneumonia; oral or intravenous therapeutic antibiotics within two weeks prior to the start of study treatment (for example, subjects who are given with preventive antibiotics for prevention of urinary tract infection or exacerbation of chronic obstructive pulmonary disease are eligible for participation in the study).
  9. Pregnant or lactating women.
  10. Other factors that may affect the study results or lead to forced termination of the study early as judged by investigators, such as alcoholism, drug abuse, other serious diseases (including mental disorders) requiring concomitant therapy, with serious laboratory examination abnormality, with family or social factors, that may affect subject's safety.

Sites / Locations

  • Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Camrelizumab combination with Apatinib

Arm Description

Apatinib (250mg p.o. q.d.) combined with Camrelizumab (200mg, iv, q2w)

Outcomes

Primary Outcome Measures

Progression-free Survival (PFS)
A duration from the date of initial treatment to disease progression (defined by RECIST 1.1) or death of any cause.

Secondary Outcome Measures

Objective Response Rate (ORR)
Proportion of patients whose tumor volume has reached a predetermined value and can maintain a minimum time limit, including complete response and partial response patients.
Overall Survival (OS)
Duration from the date of initial treatment to the date of death due to any cause.
Disease Control Rate (DCR)
Proportion of patients whose tumor volume control (reduced or enlarged) reaches a predetermined value and can maintain a minimum time limit.
Duration of Response (DoR)
Duration from the first time reported partial response or complete response to the first time of disease progression or death.
Time to Progression (TTP)
A duration from the date of initial treatment to disease progression (defined by RECIST 1.1)
Adverse events (AE)
Any adverse events related with treatment drugs and details include adverse events type, frequency and severity.

Full Information

First Posted
September 17, 2020
Last Updated
April 11, 2023
Sponsor
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04560127
Brief Title
Camrelizumab in Combination With Apatinib in Patients With Radioactive Iodine-refractory Differentiated Thyroid Cancer
Official Title
A Single-arm, Non-randomized, Single-center Study to Evaluate Camrelizumab in Combination With Apatinib in Patients With Radioactive Iodine-refractory Differentiated Thyroid Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 23, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking Union Medical College Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a single arm, open-label, non-randomized and single-center phase II clinical study, to evaluate the safety, tolerance, and efficacy of Camrelizumab in combination with Apatinib in patients with Radioactive Iodine-refractory Differentiated Thyroid Cancer (RAIR-DTC).
Detailed Description
It is estimated that 10 patients who met the study criteria will be enrolled in 1 years and treated with Camrelizumab plus Apatinib in PUMCH. The investigators will follow up and collect subjects' data to evaluate the efficacy and safety of treatment, including objective response rate (ORR) and Progression-free Survival (PFS) and Overall Survival (OS), until disease progression or death.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radioactive Iodine-refractory Differentiated Thyroid Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Camrelizumab combination with Apatinib
Arm Type
Experimental
Arm Description
Apatinib (250mg p.o. q.d.) combined with Camrelizumab (200mg, iv, q2w)
Intervention Type
Drug
Intervention Name(s)
Camrelizumab combination with Apatinib
Intervention Description
Apatinib (250mg p.o. q.d.) combined with Camrelizumab (200mg, iv, q2w)
Primary Outcome Measure Information:
Title
Progression-free Survival (PFS)
Description
A duration from the date of initial treatment to disease progression (defined by RECIST 1.1) or death of any cause.
Time Frame
two year
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
Proportion of patients whose tumor volume has reached a predetermined value and can maintain a minimum time limit, including complete response and partial response patients.
Time Frame
Time Frame: two years
Title
Overall Survival (OS)
Description
Duration from the date of initial treatment to the date of death due to any cause.
Time Frame
two years
Title
Disease Control Rate (DCR)
Description
Proportion of patients whose tumor volume control (reduced or enlarged) reaches a predetermined value and can maintain a minimum time limit.
Time Frame
two year
Title
Duration of Response (DoR)
Description
Duration from the first time reported partial response or complete response to the first time of disease progression or death.
Time Frame
two year
Title
Time to Progression (TTP)
Description
A duration from the date of initial treatment to disease progression (defined by RECIST 1.1)
Time Frame
two year
Title
Adverse events (AE)
Description
Any adverse events related with treatment drugs and details include adverse events type, frequency and severity.
Time Frame
two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. Aged after 18 years (18 is included). 2. Locally advanced or metastatic differentiated thyroid cancer (papillary, follicular, Hurthle cells, poorly differentiated carcinoma). At least one measurable lesion (helical CT scan long diameter ≥10mm, meet the requirements of the standard Response Evaluation Criteria In Solid Tumors(RESCIST) version 1.1). 3. ECOG-PS score 0-2 4. Life Expectancy of at least 12 weeks 5. Subjects must be 131I-refractory / resistant as defined by at least one of the following. Lesions that do not demonstrate iodine uptake on any radioiodine scan. Subjects received a single radioactive iodine therapy within 12 months (≥ 3.7 Giga Bequerel(GBq)[≥ 100 millicurie(mCi)]) and target lesion disease progression. Every two radioactive iodine treatment interval <12 months, doses ≥ 3.7 GBq [≥100mCi], disease progress more than 12 months after at least once iodine therapy. Received a total dose of radioactive iodine therapy ≥ 22.2 GBq (≥ 600 mCi). 6. Have the required screening laboratory values. Exclusion Criteria: Other thyroid cancer histological subtypes (such as medullary carcinoma, lymphoma or sarcoma). Any active autoimmune disease or history of autoimmune disease and expected recurrence (including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis); subjects with skin diseases that does no need systemic treatment, for example, leukoderma, psoriasis, alopecia, those with controlled type I diabetes by insulin or those with asthma that has been completely resolved in childhood and with no need of any intervention can be enrolled; while subjects with asthma who need bronchodilator for medical intervention cannot be enrolled. Use of strong CYP3A4/CYP2C19 inducers, including rifampicin (and its analogues) and St. John's Wort, or strong CYP3A4/CYP2C19 inhibitors within two weeks prior to signing informed consent form. Previous treatment with other immune checkpoint inhibitors (include PD-1 antibody or other immunotherapy against PD-1/PD-L1). Known history of serious allergy to any monoclonal antibody or Apatinib. Inability or unwilling to swallow tablets, malabsorption syndrome or any condition affecting gastrointestinal absorption. Previous or current presence of metastasis to central nervous system. Severe infection within 4 weeks prior to the start of study treatment, including but not limited to hospitalization for infection, bacteremia or complications of severe pneumonia; oral or intravenous therapeutic antibiotics within two weeks prior to the start of study treatment (for example, subjects who are given with preventive antibiotics for prevention of urinary tract infection or exacerbation of chronic obstructive pulmonary disease are eligible for participation in the study). Pregnant or lactating women. Other factors that may affect the study results or lead to forced termination of the study early as judged by investigators, such as alcoholism, drug abuse, other serious diseases (including mental disorders) requiring concomitant therapy, with serious laboratory examination abnormality, with family or social factors, that may affect subject's safety.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yan-Song Lin
Phone
8601069155610
Email
linyansong1968@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xin Zhang
Phone
8601069155610
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan-Song Lin
Phone
8601069155610

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Camrelizumab in Combination With Apatinib in Patients With Radioactive Iodine-refractory Differentiated Thyroid Cancer

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