Anlotinib or Penpulimab in Combination With RAI for DTC

NCT ID: NCT04952493

Last Updated: 2022-01-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-15
• Study Completion Date: 2024-07-20

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：

1. 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

2. Disease Control Rate (DCR)

3. 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.

4. Nuclear medicine functional imaging changes of target lesions The dynamic changes of I uptake and 18F-FDG PET/CT imaging

Conditions

Thyroid Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

anlotinib + RAI

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

Group Type: EXPERIMENTAL

Anlotinib hydrochloride

Intervention Type: DRUG

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

Sodium Iodide I 131

Intervention Type: DRUG

RAI treatment may shrink the tumor

RAI only

Patients in this arm will receive RAI treatment as scheduled.

Group Type: OTHER

Sodium Iodide I 131

Intervention Type: DRUG

RAI treatment may shrink the tumor

Penpulimab + RAI

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

Group Type: EXPERIMENTAL

Sodium Iodide I 131

Intervention Type: DRUG

RAI treatment may shrink the tumor

Penpulimab

Intervention Type: DRUG

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

Interventions

Anlotinib hydrochloride

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

Intervention Type: DRUG

Sodium Iodide I 131

RAI treatment may shrink the tumor

Intervention Type: DRUG

Penpulimab

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

Intervention Type: DRUG

Other Intervention Names

RAI

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yansong Lin

Prof. M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yansong Lin, MD

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

Peking Union Medical College Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Yansong Lin, MD

Role: CONTACT

linys@pumch.cn

+86-10-69155610

Facility Contacts

Yan-Song Lin, MD

Role: primary

linys@pumch.cn

+86-10-69155610

Other Identifiers

ALTER-T002

Identifier Type: -

Identifier Source: org_study_id