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Anlotinib or Penpulimab in Combination With RAI for DTC

Primary Purpose

Thyroid Cancer

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Anlotinib hydrochloride

Sodium Iodide I 131

Penpulimab

About this trial

This is an interventional treatment trial for Thyroid Cancer focused on measuring Anlotinib, Iodine

Eligibility Criteria

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

Inclusion Criteria:

local advanced or metastatic differentiated thyroid cancer (DTC)
scheduled to receive RAI treatment.
absence of good remission of RAI or may not get satisfactory remission from RAI treatment
At least one measurable lesion, with diameter ≥ 10mm measured by spiral MRI/CT scan per RECIST1.1.
Be 18 years of age or older, ECOG PS: 0-2. Life expectancy of at least 6 months.
Main organs function is normal.
The woman patients of childbearing age who must agree to take contraceptive methods (e.g. intrauterine device, contraceptive pill or condom) during the research and within another 6 months after it; who are not in the lactation period and examined as negative in blood serum test or urine pregnancy test within 7 days before the research; The man patients who must agree to take contraceptive methods during the research and within another 6 months after it.

Exclusion Criteria:

Patients who had previously received treatment with Antiangiogenic tyrosine kinase inhibitors, such as: Anlotinib, apatinib and Lenvatinib.
Patients who had previously received local treatment within 4 weeks or Participated in other anti-tumor clinical trials within 4 weeks.
Patients with previous or current concurrent malignancies or solid organs or bone marrow transplants within 5 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy
Unmitigated ≥ grade 2 toxicity (CTC AE 5.0) due to any prior treatment, excluding alopecia.
With kinds of factors which affect oral medicine (e.g. failing to swallow, gastrointestinal tract getting resected, chronic diarrhea and ileus)
Patients with pleural effusion or ascites.
Patients with any severe and/or uncontrolled disease.
Patients who underwent major surgery, open biopsy or significant traumatic injury within 4 weeks.
Regardless of the severity, patients with any physical signs or history of bleeding, patients with bleeding or bleeding events greater than or equal to CTCAE 2 within four weeks prior to the first administration, or patients with unhealed wounds, fractures, ulcers.
Patients with arterial or venous thromboembolic events occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism.

Sites / Locations

Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Other

Experimental

Arm Label

anlotinib + RAI

RAI only

Penpulimab + RAI

Arm Description

Patients in this arm will receive anlotinib 6 cycles around RAI treatment ( 4 cycles before and 2 cycles after RAI)

Patients in this arm will receive RAI treatment as scheduled.

Patients in this arm will receive Penpulimab from one week prior to RAI treatment until the disease progressed or intolerable.

Outcomes

Primary Outcome Measures

objective response rate (ORR)

Proportion of patients with target lesions reaching PR or CR

Secondary Outcome Measures

Disease Control Rate (DCR)

Proportion of patients with target lesions reaching PR, CR or SD

Biochemical Response Rate (BRR)

Biochemical response rate is defined as the percentage of subjects whose Tg was consecutive decreases more than 25% compared to baseline twice

Progression-free Survival (PFS) (median)

PFS was determined using the number of months measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression) of participants. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Nuclear medicine functional imaging changes of target lesions

The dynamic changes of I uptake and 18F-FDG PET/CT imaging

Full Information

NCT ID

NCT04952493

First Posted

June 27, 2021

Last Updated

January 18, 2022

Sponsor

Peking Union Medical College Hospital

Collaborators

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04952493

Brief Title

Anlotinib or Penpulimab in Combination With RAI for DTC

Official Title

The Efficacy and Safety of Anlotinib Hydrochloride or Penpulimab In Combination With RAI in Patients With Local Advanced or Metastatic Differentiated Thyroid Cancer: A Randomized, Open-label, Exploratory Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Recruiting

Study Start Date

September 15, 2021 (Actual)

Primary Completion Date

July 20, 2023 (Anticipated)

Study Completion Date

July 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Peking Union Medical College Hospital

Collaborators

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

The purpose of this study is to assess the efficacy and safety of anlotinib in combination with I-131 in locally advanced/metastatic differentiated thyroid cancer. Anlotinib may stop the growth of tumor cells and improve iodine uptake.

Detailed Description

Primary Outcome Measures: objective response rate (ORR) Secondary Outcome Measures： Biochemical Response Rate (BRR) Biochemical response rate is defined as the percentage of subjects whose Tg was consecutive decreases more than 25% compared to baseline twice Disease Control Rate (DCR) Progression-free Survival (PFS) (median) was determined using the number of months measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression) of participants. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Nuclear medicine functional imaging changes of target lesions The dynamic changes of I uptake and 18F-FDG PET/CT imaging

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Thyroid Cancer

Keywords

Anlotinib, Iodine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

anlotinib + RAI

Arm Type

Experimental

Arm Description

Patients in this arm will receive anlotinib 6 cycles around RAI treatment ( 4 cycles before and 2 cycles after RAI)

Arm Title

RAI only

Arm Type

Other

Arm Description

Patients in this arm will receive RAI treatment as scheduled.

Arm Title

Penpulimab + RAI

Arm Type

Experimental

Arm Description

Patients in this arm will receive Penpulimab from one week prior to RAI treatment until the disease progressed or intolerable.

Intervention Type

Drug

Intervention Name(s)

Anlotinib hydrochloride

Intervention Description

Anlotinib hydrochloride may stop the growth of tumor cells and improve iodine uptake.

Intervention Type

Drug

Intervention Name(s)

Sodium Iodide I 131

Other Intervention Name(s)

RAI

Intervention Description

RAI treatment may shrink the tumor

Intervention Type

Drug

Intervention Name(s)

Penpulimab

Intervention Description

Penpulimab is a novel structure Immune checkpoint inhibitor. The combination of Penpulimab and RAI might have synergistic effects for DTC.

Primary Outcome Measure Information:

Title

objective response rate (ORR)

Description

Proportion of patients with target lesions reaching PR or CR

Time Frame

up to 24 months

Secondary Outcome Measure Information:

Title

Disease Control Rate (DCR)

Description

Proportion of patients with target lesions reaching PR, CR or SD

Time Frame

up to 24 months

Title

Biochemical Response Rate (BRR)

Description

Biochemical response rate is defined as the percentage of subjects whose Tg was consecutive decreases more than 25% compared to baseline twice

Time Frame

up to 24 months

Title

Progression-free Survival (PFS) (median)

Description

Time Frame

up to 24 months

Title

Nuclear medicine functional imaging changes of target lesions

Description

The dynamic changes of I uptake and 18F-FDG PET/CT imaging

Time Frame

up to 24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: local advanced or metastatic differentiated thyroid cancer (DTC) scheduled to receive RAI treatment. absence of good remission of RAI or may not get satisfactory remission from RAI treatment At least one measurable lesion, with diameter ≥ 10mm measured by spiral MRI/CT scan per RECIST1.1. Be 18 years of age or older, ECOG PS: 0-2. Life expectancy of at least 6 months. Main organs function is normal. The woman patients of childbearing age who must agree to take contraceptive methods (e.g. intrauterine device, contraceptive pill or condom) during the research and within another 6 months after it; who are not in the lactation period and examined as negative in blood serum test or urine pregnancy test within 7 days before the research; The man patients who must agree to take contraceptive methods during the research and within another 6 months after it. Exclusion Criteria: Patients who had previously received treatment with Antiangiogenic tyrosine kinase inhibitors, such as: Anlotinib, apatinib and Lenvatinib. Patients who had previously received local treatment within 4 weeks or Participated in other anti-tumor clinical trials within 4 weeks. Patients with previous or current concurrent malignancies or solid organs or bone marrow transplants within 5 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy Unmitigated ≥ grade 2 toxicity (CTC AE 5.0) due to any prior treatment, excluding alopecia. With kinds of factors which affect oral medicine (e.g. failing to swallow, gastrointestinal tract getting resected, chronic diarrhea and ileus) Patients with pleural effusion or ascites. Patients with any severe and/or uncontrolled disease. Patients who underwent major surgery, open biopsy or significant traumatic injury within 4 weeks. Regardless of the severity, patients with any physical signs or history of bleeding, patients with bleeding or bleeding events greater than or equal to CTCAE 2 within four weeks prior to the first administration, or patients with unhealed wounds, fractures, ulcers. Patients with arterial or venous thromboembolic events occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yansong Lin, MD

Phone

+86-10-69155610

linys@pumch.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yansong Lin, MD

Organizational Affiliation

Peking Union Medical College Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Peking Union Medical College Hospital

City

Beijing

ZIP/Postal Code

100730

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yan-Song Lin, MD

Phone

+86-10-69155610

linys@pumch.cn

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Anlotinib or Penpulimab in Combination With RAI for DTC

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