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New treatment option for Esophageal Squamous Cell Carcinoma
Official title Perioperative Tislelizumab Plus Chemotherapy for Resectable Thoracic Oesophageal Squamous Cell Carcinoma
ClinicalTrials.gov ID: NCT06056336
What this study is testing
What is Tislelizumab?
Tislelizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for esophageal squamous cell carcinoma.
Also referred to as Albumin-bound Paclitaxel, Carboplatin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to analyze esophageal cancer patients who underwent neoadjuvant immunotherapy with chemotherapy followed by esophagectomy to determine whether additional adjuvant therapy is associated with improved survival outcomes.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- The patient volunteers to participate in the study, signs a consent form, has good compliance, and obeys the follow-up, and is willing and able to...
- Histologically-confirmed squamous cell carcinoma; tumors of the esophagus are located in the thoracic cavity;
- Have not received systemic and local treatment for esophageal cancer;
- Pre-treatment staging as cT1b-3N1-3M0 or T3N0M0, American Joint Committee on Cancer (AJCC)/Union for International Cancer Control (UICC) 8th edition;
- Male or female, aged ≥18 and ≤75 years;
You likely can't join if
- Unresectable factors, including those who are unresectable for tumor reasons or have surgical contraindications, or who refuse surgery;
- Patients with supraclavicular lymph node metastasis;
- Poor nutritional status, BMI\<18.5Kg/m2; Patients could continue to be considered for enrollment if corrected with symptomatic nutritional support...
- Allergy to any drugs;
- Have received or are receiving any of the following treatments; a) any radiotherapy, chemotherapy or other antineoplastic drugs directed at the...
- Human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) active infection or known HIV seropositivity; including HBV or...
See the full eligibility criteria
- The patient volunteers to participate in the study, signs a consent form, has good compliance, and obeys the follow-up, and is willing and able to follow the protocol during the study;
- Histologically-confirmed squamous cell carcinoma; tumors of the esophagus are located in the thoracic cavity;
- Have not received systemic and local treatment for esophageal cancer;
- Pre-treatment staging as cT1b-3N1-3M0 or T3N0M0, American Joint Committee on Cancer (AJCC)/Union for International Cancer Control (UICC) 8th edition;
- Male or female, aged ≥18 and ≤75 years;
- The Eastern Cooperative Oncology Group (ECOG) performance status (PS) score is 0 -1;
- R0 resection is expected;
- Adequate cardiac function. All patients should perform electrocardiogram (ECG), and those with a cardiac history or ECG abnormality should perform echocardiography with the left ventricular ejection fraction \>50%;
- Adequate respiratory function with forced expiratory volume in 1 second (FEV1) ≥ 1.2 L, FEV1% ≥ 50% and lung diffusing capacity for carbon monoxide (DLCO) ≥ 50% shown in pulmonary function tests;
- Adequate bone marrow function (white blood cells \> 4×109/L, neutrophil \> 1.5 ×109/L, hemoglobin \> 90g/L, platelets \> 100×109/L). Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 3× upper level of...
- Adequate liver function (total bilirubin \<1.5× ULN, AST and ALT \<2.5× ULN);
- Adequate renal function (glomerular filtration rate (GFR) \>60 mL/min; serum creatinine (SCr) ≤120 μmol/L];
- Fertile female people are required to have a negative serum or urine pregnancy test no later than 72 hours before starting the study drug administration, and to use effective contraception (such as an IUD, contraceptive...
- Unresectable factors, including those who are unresectable for tumor reasons or have surgical contraindications, or who refuse surgery;
- Patients with supraclavicular lymph node metastasis;
- Poor nutritional status, BMI\<18.5Kg/m2; Patients could continue to be considered for enrollment if corrected with symptomatic nutritional support before enrollment and after assessment by the principal investigator
- Allergy to any drugs;
- Have received or are receiving any of the following treatments; a) any radiotherapy, chemotherapy or other antineoplastic drugs directed at the tumour; b) being treated with an immunosuppressive drug or systemic hormone...
- Human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) active infection or known HIV seropositivity; including HBV or HCV surface antigen positive (RNA)
- Uncontrolled cardiac symptoms or diseases, including but not limited to: (1) heart failure above NYHA class II, (2) unstable angina, (3) myocardial infarction within 1 year, (4) clinically significant supraventricular...
- Severe infection (CTCAE\>2) occurred within 4 weeks before the first dose of study drug, such as severe pneumonia requiring hospitalization, bacteremia, and infectious complications; Prophylactic antibiotics were...
- Participation in other drug clinical studies within 4 weeks before randomization;
- Patients with interstitial pneumonia or interstitial lung disease, or previous history of interstitial pneumonia or interstitial lung disease requiring hormone therapy, or other people with pulmonary fibrosis, organized...
- Patients with any active autoimmune disease or history of autoimmune disease and possible recurrence [including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis...
- Other malignancies that had been diagnosed within 5 years before the first dose of a study drug were considered unless cancers with a low risk of metastasis or death (5-year survival rate, \>90%), such as adequately...
- Pregnant or lactating women;
- The investigators determined that there were other factors that might have led to the forced discontinuation of the study, such as other serious medical conditions (including mental illness) requiring co-treatment...
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.