Clinical studies confirming the usefulness of preoperative nivolumab treatment for operable esophageal squamous cell carcinoma
- Conditions
- Neoplasms
- Registration Number
- KCT0004189
- Lead Sponsor
- Samsung Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
1.Histologically confirmed esophageal squamous cell carcinoma
2.Clinical stage T2N0 (invasion to muscularis propria) or T3N0 (invasion to adventitia)
3.No prior therapy (operation, radiotherapy, immunotherapy, or chemotherapy) for esophageal cancer
4.Age 19 years or older
5.ECOG performance 0 or 1
6.A female participant is eligible to participate if she is not pregnant, not breastfeeding, and agrees to follow contraceptive guideline.
7.A male participant must agree to use contraception during the treatment period and for at least 180 days (a spermatogenesis cycle) for study treatments with evidence of genotoxicity at any dose after the last dose of study treatment and refrain from donating sperm during this period.
8.The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
9.Subjects who have been fully informed or the nature of the study through the informed consent form by the investigator and gave their consent for voluntary participation in the study
10. If there is sufficient organs and bone marrow function in the test within 14 days of the start of treatment.
- Adequate organ function as evidenced by the following: Hb = 8.0g/dl, Absolute neutrophil count = 1.0 x 109/L total bilirubin =1.5 UNL except subjects Gilbert’s syndrome (=3 X ULN); AST and/or ALT < 2.5 UNL; creatinine clearance = 40 mL/min by the Cockcroft-Gault formula [male: weight (kg) x (140-age) / (72 x serum creatinine), female: weight (kg) x (140-age) x 0.85/(72 x serum creatinine)]
Exclusion Criteria
1.Has received a live vaccine within 30 days prior to the first dose of study drug. (eg: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette–Guérin (BCG), and typhoid vaccine). Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed.
2.Patients enrolled in other clinical studies(However, observational studies are irrelevant)
3.Ineligibility or contraindication for esophagectomy
4.Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
5.Has a known additional malignancy that is progressing or has required active treatment within the past 2 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, well differentiated thyroid carcinoma, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded. In addition, early gastric or bladder cancer that completely resected with endoscopic resection are not excluded, even if the procedure was performed within 2 years.
6.Has severe hypersensitivity and adverse events (=Grade 3) to nivolumab and/or any PD-1/PD-L1 inhibitors.
7.Active or previously documented autoimmune disease or inflammatory disease (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [Excluding diverticulum], Systemic lupus erythematosus, sarcoidosis syndrome or Wegener syndrome [Granulomatosis with polyangiitis, Gaves disease, rheumatoid arthritis, hypophysitis, uveiti and the like] include). Exceptions to this criterion include:
- Patient with vitiligo or alopecia
- Patients with hypothyroidism who are receiving hormone replacement therapy stably. (e.g., after Hashimoto`s syndrome)
- a chronic skin disease that does not require full-body therapy.
- the celiac disease are controlled by food.
- Patients without active disease within the past five years can only be selected after consultation with a clinical trial physician.
8.Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
9.Has an active infection requiring systemic therapy.
10.Has a known history of Human Immunodeficiency Virus (HIV)
11.TB (clinical assessment includes clinical past history, physical exam and radiological findings, and TB testing on local care), Active infection, such as hepatitis C or human immunodeficiency virus (positive HIV 1/2 antibody). However, patients with hepatitis C (HCV) antibody positive are only suitable if the polymerase chain reaction to HCV RNA is negative. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection.
12.Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject’s participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
13.Is pregnant or breast feeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 180 days af
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method major pathologic response rate
- Secondary Outcome Measures
Name Time Method Objective response rate (according to RECIST (Response evaluation criteria in solid tumors) guideline);PET-CT response;Progression-free survival;Overall survival;Safety;Exploratory Objective