Thyroid CancerPhase 2NCT04952493
Anlotinib or Penpulimab in Combination With RAI for DTC
A Phase 2 study testing Anlotinib hydrochloride, Sodium Iodide I 131 and Penpulimab in people with Thyroid Cancer, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Cancer
- What is being tested?
- Anlotinib hydrochloride, Sodium Iodide I 131 and Penpulimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2021to 20 Jul 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, 100730
Yan-Song Lin, MD, +86-10-69155610, linys@pumch.cn
About this study
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
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.
Read the 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
- Conditions
- Thyroid Cancer
- Being tested
- Anlotinib hydrochloride, Sodium Iodide I 131, Penpulimab
- Keywords
- Anlotinib, Iodine
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anlotinib hydrochlorideDrug
Anlotinib hydrochloride may stop the growth of tumor cells and improve iodine uptake.
Sodium Iodide I 131Drug
Also called RAI
RAI treatment may shrink the tumor
PenpulimabDrug
Penpulimab is a novel structure Immune checkpoint inhibitor. The combination of Penpulimab and RAI might have synergistic effects for DTC.
| Study group | Role | What they receive |
|---|---|---|
| anlotinib + RAI | Experimental | Patients in this arm will receive anlotinib 6 cycles around RAI treatment ( 4 cycles before and 2 cycles after RAI) Receives: Drug: Anlotinib hydrochloride; Drug: Sodium Iodide I 131 |
| RAI only | Other | Patients in this arm will receive RAI treatment as scheduled. Receives: Drug: Sodium Iodide I 131 |
| Penpulimab + RAI | Experimental | Patients in this arm will receive Penpulimab from one week prior to RAI treatment until the disease progressed or intolerable. Receives: Drug: Sodium Iodide I 131; Drug: Penpulimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate (ORR)
Proportion of patients with target lesions reaching PR or CR
Measured: up to 24 months
Secondary outcomes (4)
Disease Control Rate (DCR)
Proportion of patients with target lesions reaching PR, CR or SD
Measured: up to 24 months
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
Measured: up to 24 months
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
Measured: up to 24 months
Nuclear medicine functional imaging changes of target lesions
The dynamic changes of I uptake and 18F-FDG PET/CT imaging
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study start15 Sep 2021
- Primary completion20 Jul 2023 (estimated)
- Study completion20 Jul 2024 (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 Peking Union Medical College HospitalThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Responsible party
- Principal investigator, Yansong Lin, Peking Union Medical College Hospital
- Investigators
- Yansong Lin, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04952493
- Sponsor's protocol ID
- ALTER-T002
- Status last verified
- Aug 2021
- First submitted
- 27 Jun 2021
- Last updated
- 28 Jan 2022
- Results posted
- 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 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04952493
- Acronym / sponsor ID
- ALTER-T002
- Conditions
- Thyroid Cancer
- Keywords
- Anlotinib, Iodine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 20 Jul 2023 (estimated)
- Study completion
- 20 Jul 2024 (estimated)
- First posted
- 7 Jul 2021 (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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| anlotinib + RAI | Experimental | Drug: Anlotinib hydrochloride, Drug: Sodium Iodide I 131Patients in this arm will receive anlotinib 6 cycles around RAI treatment ( 4 cycles before and 2 cycles after RAI) |
| RAI only | Other | Drug: Sodium Iodide I 131Patients in this arm will receive RAI treatment as scheduled. |
| Penpulimab + RAI | Experimental | Drug: Sodium Iodide I 131, Drug: PenpulimabPatients in this arm will receive Penpulimab from one week prior to RAI treatment until the disease progressed or intolerable. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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)
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 |
|---|---|---|
| Anlotinib hydrochlorideAnlotinib hydrochloride may stop the growth of tumor cells and improve iodine uptake. | Drug | anlotinib + RAI |
| Sodium Iodide I 131Also: RAIRAI treatment may shrink the tumor | Drug | Penpulimab + RAI, RAI only, anlotinib + RAI |
| PenpulimabPenpulimab is a novel structure Immune checkpoint inhibitor. The combination of Penpulimab and RAI might have synergistic effects for DTC. | Drug | Penpulimab + RAI |
Primary outcome
objective response rate (ORR)
Time frame: up to 24 months
Proportion of patients with target lesions reaching PR or CR
4 secondary outcomes
Disease Control Rate (DCR)
Time frame: up to 24 months
Biochemical Response Rate (BRR)
Time frame: up to 24 months
Progression-free Survival (PFS) (median)
Time frame: up to 24 months
Nuclear medicine functional imaging changes of target lesions
Time frame: up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2022.
- 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.
Yansong Lin, MD principal investigator
Peking Union Medical College Hospital
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 Anlotinib hydrochloride, Sodium Iodide I 131 and Penpulimab in people with Thyroid Cancer, run by Peking Union Medical College Hospital 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 10 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 28 Jan 2022. 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 Yansong Lin, MD (+86-10-69155610, linys@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective response rate (ORR) (time frame: up to 24 months). 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 28 Jan 2022.