PD-1 Inhibitor and Anlotinib Combined With Multimodal Radiotherapy in Recurrent or Metastatic Ana… (NCT05659186) | Clinical Trial Compass
UnknownPhase 2
PD-1 Inhibitor and Anlotinib Combined With Multimodal Radiotherapy in Recurrent or Metastatic Anaplastic Thyroid Cancer
China20 participantsStarted 2022-12-30
Plain-language summary
The purpose of this study is to evaluate the efficacy and safety of PD-1 inhibitor and anlotinib combined with multimodal radiotherapy for the second-line treatment of recurrent or metastatic anaplastic thyroid cancer.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age 18 years or above.
✓. Patients with pathologically confirmed Undifferentiated thyroid carcinoma and meet the following conditions:
✓. Were diagnosed with distant metastasis;
✓. Were intolerant to or failed first-line treatment.
✓. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
✓. Expected life is greater than or equal to 12 weeks.
✓. There is at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
✓. Adequate organ and bone marrow function:
Exclusion criteria
✕. Existing tumor-related hemorrhage。
✕. History of other malignancies (except for the history of malignant tumors that have been cured and have not recurred within 5 years, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, in situ cervical cancer, and gastrointestinal mucosal cancer, etc.）
✕. Have an active autoimmune disease requiring systemic treatment or a documented history of clinically severe autoimmune disease.
✕. Any history of allergic disease, severe hypersensitivity reaction to drugs, or allergy to the study drug components.
✕. Toxicity from prior antitumor therapy has not recovered to ≤ CTCAE Version 5.0 Grade 1 or the level specified by the inclusion/exclusion criteria.
✕. Antitumor vaccine;
✕. Any active vaccine against infectious disease within 4 weeks prior to the first dose or planned during the study period;