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New treatment option for Esophagus Cancer
Official title Neoadjuvant Comprehensive Treatment for Unresectable Esophageal Cancer
ClinicalTrials.gov ID: NCT06430658
What this study is testing
What is Tislelizumab (BGB-A317) with chemoradiotherapy?
Tislelizumab (BGB-A317) with chemoradiotherapy is an investigational medicine, being studied as a potential treatment for esophagus cancer.
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
- Patients diagnosed with locally advanced esophageal squamous cell carcinoma (ESCC) that is deemed unresectable face a bleak prognosis. Recent phase 1/2 studies have demonstrated the efficacy and safety of augmenting neoadjuvant concurrent chemoradiotherapy with immunotherapy in treating resectable ESCC.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
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
- Histologically confirmed sorely ESCC without other histology subtypes.
- Thoracic esophageal cancer.
- No prior anti-cancer treatment, including but not limited to surgery, radiotherapy, chemotherapy, targeted therapy, or immunotherapy.
- Borderline unresectable locally advanced ESCC deemed by investigators as suspicious of but not confirmed T4b according to the American Joint...
- The Karnofsky Performance Scale (KPS) ≥70.
You likely can't join if
- Synchronous and metachronous primary malignancies in but not limited to the upper aerodigestive tract, except for cured basal cell carcinoma of the...
- Patients have undergone any type of anti-cancer treatment.
- Baseline clinical stage M1 per AJCC 8th edition of staging classification, including supraclavicular lymph node metastases.
- Investigators assessed major vessel involvement with high-risk hemorrhage.
- A higher probability of esophageal perforation during conversion therapy.
- Active infectious diseases, including but not limited to tuberculosis, hepatitis B virus, or hepatitis C virus.
See the full eligibility criteria
- Histologically confirmed sorely ESCC without other histology subtypes.
- Thoracic esophageal cancer.
- No prior anti-cancer treatment, including but not limited to surgery, radiotherapy, chemotherapy, targeted therapy, or immunotherapy.
- Borderline unresectable locally advanced ESCC deemed by investigators as suspicious of but not confirmed T4b according to the American Joint Committee on Cancer (AJCC) 8th edition staging classification or extracapsular...
- The Karnofsky Performance Scale (KPS) ≥70.
- Normal primary organ functions, including but not limited to hemoglobin (Hb) ≥ 100g/L; white blood cell (WBC) ≥ 3.5×10\ 9/L; neutrophil count (NEUT) ≥ 1.5×10\ 9/L; platelets (PLT) ≥ 100×10\ 9/L; alanine aminotransferase...
- Synchronous and metachronous primary malignancies in but not limited to the upper aerodigestive tract, except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix.
- Patients have undergone any type of anti-cancer treatment.
- Baseline clinical stage M1 per AJCC 8th edition of staging classification, including supraclavicular lymph node metastases.
- Investigators assessed major vessel involvement with high-risk hemorrhage.
- A higher probability of esophageal perforation during conversion therapy.
- Active infectious diseases, including but not limited to tuberculosis, hepatitis B virus, or hepatitis C virus.
- Allergic to anti-cancer agents, including but not limited to anti-PD-1 or chemotherapy agents.
- Given cardiopulmonary dysfunction, patients can not tolerate conversion therapy or surgery.
- Pregnant or lactating women and women of childbearing potential who lacked effective contraception.
- Non-compliance with the inclusion criteria judged by investigators.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, 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 Beijing, 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.