Anlotinib or Penpulimab in Combination With RAI for DTC

NCT04952493 | Unknown Phase 2

• 1 other identifier: ALTER-T002
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid Cancer

Keywords

Anlotinib; Iodine

Outcome Measures

Primary Outcomes (1)

• objective response rate (ORR)

  Proportion of patients with target lesions reaching PR or CR

  up to 24 months

Secondary Outcomes (4)

• Disease Control Rate (DCR)

  up to 24 months

• Biochemical Response Rate (BRR)

  up to 24 months

• Progression-free Survival (PFS) (median)

  up to 24 months

• Nuclear medicine functional imaging changes of target lesions

  up to 24 months

Study Arms (3)

anlotinib + RAI

EXPERIMENTAL

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

Drug: Anlotinib hydrochloride; Drug: Sodium Iodide I 131

RAI only

OTHER

Patients in this arm will receive RAI treatment as scheduled.

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.

Drug: Sodium Iodide I 131; Drug: Penpulimab

Interventions

Anlotinib hydrochloride DRUG

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

anlotinib + RAI

Sodium Iodide I 131 DRUG

RAI treatment may shrink the tumor

Also known as: RAI

Penpulimab + RAI; RAI only; anlotinib + RAI

Penpulimab DRUG

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

Penpulimab + RAI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: collaborator

Study Sites (1)

Peking Union Medical College Hospital

Beijing, 100730, China

RECRUITING

MeSH Terms

Conditions

Thyroid Neoplasms

Interventions

Iodine-131; penpulimab

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Officials

• Yansong Lin, MD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yansong Lin, MD

CONTACT

+86-10-69155610; linys@pumch.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. M.D.

Study Record Dates

• First Submitted: June 27, 2021
• First Posted: July 7, 2021
• Study Start: September 15, 2021
• Primary Completion: July 20, 2023
• Study Completion: July 20, 2024
• Last Updated: January 28, 2022

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)