ChemoRadiation And Tislelizumab for Esophageal/EGJ Cancer

NCT05245760 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: MCC-21-LUN-125-PMC
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to determine the effects of chemoradiation and Tislelizumab on Esophageal/EGJ Cancer before and after surgery.

Conditions

Esophageal Cancer; Esophagogastric Junction Cancer

Outcome Measures

Primary Outcomes (1)

• Pathological complete response rate (pCR)

  Pathological complete response (pCR) rate in patients treated with tislelizumab and chemoradiation followed by surgery. The pCR rate will be estimated by number of patients who has had pCR divided by the total number of evaluable patients treated with neoadjuvant therapy before surgery. The exact 95% confidence interval of the pCR rate will be provided.

  12 months

Secondary Outcomes (2)

• Progression free survival (PFS)

  12 months

• Major pathological response (MPR)

  12 months

Study Arms (1)

All patient

EXPERIMENTAL

All patients receive Tislelizumab, q3week; chemotherapy with carboplatin and paclitaxel weekly concurrently for 5 weeks before surgery. Tislelizumab is continued q3week in all patients after surgery for a total of one year from the start of study.

Drug: Intravenous Tislelizumab; Drug: Chemotherapy; Radiation: Fractionated radiation; Procedure: Esophagectomy

Interventions

Intravenous Tislelizumab DRUG

Participants will receive 200mg, every three weeks for up to 51 weeks

Also known as: immunotherapy

All patient

Chemotherapy DRUG

Carboplatin (AUC2) and Paclitaxel (50mg/m2), Weekly x 5 weeks

Also known as: carboplatin and paclitaxel

All patient

Fractionated radiation RADIATION

Concurrent with chemo, x5 weeks

All patient

Esophagectomy PROCEDURE

Surgical resection of cancer after chemoradiation therapy when no disease progression found.

All patient

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to provide written informed consent and can understand and agree to comply with the requirements of the study and the schedule of assessments
• Age ≥ 18 years but 80 years or younger on the day of signing the informed consent form.
• Histologically proven esophageal squamous cell cancer or adenocarcinoma.
• De novo diagnosis, have not received prior treatment
• AJCC 8. T1N1 or T2-4aN0-2M0 resectable disease
• ECOG Performance Status ≤ 1
• Adequate organ function as indicated by the following laboratory values
• a. Patients must not have required a blood transfusion or growth factor support ≤ 14 days before sample collection at screening for the following i. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L ii. Platelets ≥ 100 x 109/L iii. Hemoglobin ≥ 90 g/L b. Serum creatinine ≤ 1.5 x ULN (upper limit of normal) or estimated Glomerular Filtration Rate ≥ 60 mL/min/1.73 m2 c. Serum total bilirubin ≤ 1.5 x ULN (total bilirubin must be \< 3 x ULN for patients with Gilberts syndrome). d. AST and ALT ≤ 3 x ULN
• Females of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study, and ≥ 120 days after the last dose of tislelizumab, and have a negative urine or serum pregnancy test ≤ 7 days before the first dose of tislelizumab.
• Non-sterile males must be willing to use a highly effective method of birth control for the duration of the study and for ≥ 120 days after the last dose of tislelizumab

You may not qualify if:

• Unresectable disease either T4b or M1 per AJCC8
• Deemed inoperable for any reason by attending surgeon
• Any prior treatment directed at the tumor except biopsy.
• Active autoimmune diseases such as SLE, RA requiring systemic immunosuppression or history of autoimmune diseases that may relapse.
• Any active malignancy ≤ 2 years before first dose of study drug, except for cancer that has been treated curatively (e.g., resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast)
• Any condition that required systemic treatment with either corticosteroids (\> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before tislelizumab. Note: Patients who are currently or have previously been on any of the following steroid regimens are not excluded:
• Adrenal replacement steroid (dose ≤ 15 mg daily of prednisone or equivalent)
• Topical, ocular, intra-articular, intranasal, or inhaled corticosteroid with minimal systemic absorption
• Short course (≤ 7 days) of corticosteroid prescribed prophylactically (e.g., for contrast dye allergy) or for the treatment of a non-autoimmune condition (e.g., delayed-type hypersensitivity reaction caused by contact allergen)
• Laboratory test abnormalities in potassium, sodium, or corrected calcium \> Grade 1 despite standard medical management
• History of interstitial lung disease, non-infectious pneumonitis or uncontrolled diseases including pulmonary fibrosis, acute lung diseases, etc.
• Severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy, including tuberculosis infection, etc.
• A known history of HIV infection not controlled with anti-retroviral therapy
• Patients with untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers whose HBV DNA is \> 500 IU/mL or patients with active hepatitis C virus (HCV) should be excluded. Note: Inactive hepatitis B surface antigen (HBsAg) carriers, treated and stable hepatitis B (HBV DNA \< 500 IU/mL), and cured hepatitis C patients can be enrolled
• Prior allogeneic stem cell transplantation or organ transplantation

Sponsors & Collaborators

• Zhonglin Hao: lead
• BeiGene: collaborator
• University of Kentucky: collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Immunotherapy; Drug Therapy; Carboplatin; Paclitaxel; Esophagectomy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Immunomodulation; Biological Therapy; Therapeutics; Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Zhonglin Hao, MD, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: February 18, 2022
• Study Start: April 1, 2022
• Primary Completion: March 1, 2023
• Study Completion (Estimated): December 1, 2033
• Last Updated: November 8, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)