Tislelizumab Combined With Chemotherapy or Radiotherapy in the Treatment of Advanced or Recurrent Metastatic Elderly Esophageal Cancer

Fujian Cancer Hospital0 sites130 target enrollmentSeptember 30, 2024

ConditionsEsophageal Cancer

InterventionsTislelizumab Radiation Paclitaxel

DrugsTislelizumab Paclitaxel Platinum: cisplatin, carboplatin, naidaplatin and other platinum drugs

Overview

Phase: Phase 2
Intervention: Tislelizumab
Conditions: Esophageal Cancer
Sponsor: Fujian Cancer Hospital
Enrollment: 130
Primary Endpoint: objective response rate
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

To compare the objective response rate (ORR) and safety of tislelizumab combined with chemotherapy and Tislelizumab combined with radiotherapy in elderly patients with esophageal cancer with advanced or recurrent metastasis

Registry

clinicaltrials.gov

Start Date

September 30, 2024

End Date

September 30, 2027

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Fujian Cancer Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Signed a written informed consent and volunteered to join the study;
•Patients with esophageal squamous cell carcinoma confirmed by pathological histological and / or immunohistochemical examination or progressing after surgical resection, (the 8th edition, 2017) with UICC / AJCC TNM stage cT4N0-2M0, c any TN3M0, or c any T any NM1 (clinical stage IV);
•Unresectable advanced, recurrent, or metastatic oesophageal SCC;
•Age: 70 years old;
•E CO G P S 0-2
•Has not received any systemic antitumor treatment for esophageal cancer, including radiotherapy, chemotherapy, targeted, immunotherapy, etc.;
•At least one measurable lesion was present
•Main organs have normal function, including:
•A) Routine blood tests (no blood components, cell growth factors, whitening agents, platelets, anemia drugs are allowed within 14 days before the first use of the study drug) Leukocyte count was at 3.0109/L Neutrophil count was at 1.0109/L Platelet count was at 8,0109/L Hemoglobin was at 80 g / L b) Blood biochemical examination: Total bilirubin was at 1.5 ULN ALT ≤ 2.5×ULN ，AST ≤2.5×ULN ， Serum creatinine of 1.5 ULN, or creatinine clearance of 45 mL/min (Cocheroft-Gault formula, see Annex 2)
•The subjects had good compliance and cooperated with the follow-up

Exclusion Criteria

•There is uncontrollable pleural effusion, pericardial effusion or ascites that requires repeated drainage;
•Poor nutritional status, BMI \<18.5 Kg / m2; if corrected after symptomatic nutritional support, further enrollment can be considered after evaluation by the principal investigator;
•Gastrointestinal bleeding (bleeding volume\> 200ml / day);
•Patients adjudged by the researchers to have deep ulcers;
•Previous history of allergy to monoclonal antibodies, any component of tirellizumab, paclitaxel, cisplatin, or other platinum drugs;
•Has received or are receiving any of the following treatments:
•A) Any radiotherapy, chemotherapy, or other antitumor drugs directed against the tumor; Study drug b) Treatment with immunosuppressive drugs or systemic hormones for immunosuppression purposes within 2 weeks of the first study drug (dose or equivalent dose\> 10mg / day); inhaled or topical steroids and doses\> 10mg / day prednisone or equivalent dose of adrenal corticoid replacement in the absence of active autoimmune disease; The c) Acceptance of a live attenuated vaccine within 4 weeks before the first use of the study drug; d) Major surgery or severe trauma within 4 weeks prior to the first use of the study drug;
•History of any active autoimmune or autoimmune disease, including but not limited to: interstitial pneumonia, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (considered after HRT); patients with psoriasis or asthma / allergy in childhood remission and adults without any intervention, but patients requiring bronchodilator are not included;
•A history of immunodeficiency, including positive HIV testing, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation or allogeneic bone marrow transplantation;
•Poor clinical cardiac symptoms or disease, including but not limited to: