Toripalimab in Combination With Chemotherapy as Induced Chemotherapy for Localized Hypopharyngeal… (NCT04296747) | Clinical Trial Compass
UnknownPhase 2
Toripalimab in Combination With Chemotherapy as Induced Chemotherapy for Localized Hypopharyngeal Cancer
100 participantsStarted 2020-03
Plain-language summary
60% of hypopharyngeal cancers were locally advanced at the time of diagnosis. The standard treatment was surgery and postoperative radiotherapy. Compared with traditional surgery and postoperative radiotherapy, induction chemotherapy combined with radiotherapy has a better laryngeal retention rate without reducing the curative effect, and established an organ function preservation treatment strategy. Induction chemotherapy can reduce tumor burden and reduce distant metastases. At present, induction chemotherapy followed by concurrent chemoradiotherapy has become the standard treatment for the laryngeal preservation in locally advanced hypopharyngeal and laryngeal cancer. This study aimed to investigate the efficacy and safety of a PD-1 inhibitor toripalimab combined with chemotherapy as induction therapy in hypopharyngeal cancer.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥ 18 years when signing informed consent.
✓. The initial diagnosis is T1N + M0, T2-4 anyNM0 according to the 8th edition of AJCC.
✓. Patients who is suitable and agrees to radical treatment.
✓. With evaluable lesions according to the RECIST version 1.1. Note: According to the RECIST 1.1, evaluable lesions refers to a lesion that has been previously treated with radiotherapy. If a clear tumor progression appearance then, it can be used as a measurable lesion.
✓. ECOG PS ≤1
✓. Adequate organ function, defined as achieving the following laboratory test results ≤ 14 days before treatment
✓. Note: Patients must not receive blood transfusion or growth factor within 14 days before blood sample collection due to neutrophil count, platelet, or hemoglobin below study requirements.
. Not suitable for any of the two-drug chemotherapy prescribed in the protocol
✕. Have previously received any treatment for hypopharyngeal squamous cell carcinoma.
✕. Patients with evidence of fistula (esophagus / bronchus or esophagus / aorta)
✕. Presence of uncontrollable pleural effusion, pericardial effusion, or ascites that require repeated drainage or medical intervention (with clinically significant recurrence requiring additional intervention within 2 weeks after the intervention).
✕. Evidence of complete esophageal obstruction that is not suitable for treatment
✕. Have been treated with antitumor agents targeted to PD-1, PD-L1 or PD-L2.
✕. Have active meningeal disease or uncontrolled brain metastases:
✕. Patients with active autoimmune disease or history of autoimmune diseases may relapse.