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New treatment option for Esophageal Cancer
Official title Neoadjuvant PD-1 Blockade for Elderly Esophageal Squamous Cell Carcinoma (BLESS)
ClinicalTrials.gov ID: NCT06385730
What this study is testing
What is neoadjuvant anti-PD-1?
neoadjuvant anti-PD-1 is an investigational medicine, being studied as a potential treatment for esophageal 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
- The investigators will conduct a prospective phase 2 study to evaluate the efficacy and safety of neoadjuvant PD-1 blockade monotherapy with toripalimab in elderly patients with locally advanced resectable esophageal squamous cell carcinoma (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 76 and older
You may be able to join if
- people signed the informed consent and volunteered to participate in the study.
- Esophageal squamous cell carcinoma confirmed by histology or cytology.
- Thoracic esophageal squamous cell carcinoma confirmed by CT or pet-CT, which is classified as T1N1-3M0 or T2-3N0-3M0 (M1 lymph node metastasis...
- Expect to have R0 resection
- In age \>75.
You likely can't join if
- 1.people have received or are receiving any of:
- anti-tumor interventions such as radiotherapy, chemotherapy, immunotherapy or other medictions.
- Received systemic corticosteroid therapy (prednisone equivalence\> 10mg/d) or other immunosuppressive agents within the first 2 weeks prior to the...
- live vaccine within 4 weeks before the first administration. 2\. Cancer related exclusion criteria
- other cancers instead of ESCC
- non-recetable or metastatic ESCC
See the full eligibility criteria
- people signed the informed consent and volunteered to participate in the study.
- Esophageal squamous cell carcinoma confirmed by histology or cytology.
- Thoracic esophageal squamous cell carcinoma confirmed by CT or pet-CT, which is classified as T1N1-3M0 or T2-3N0-3M0 (M1 lymph node metastasis confined to the supraclavicular lymph nodes) (AJCC 8th).
- Expect to have R0 resection
- In age \>75.
- ECOG PS: 0\~1.
- Have not received any anti-tumor treatment for esophageal cancer in the past, including radiotherapy, chemotherapy, surgery, etc.
- No contraindications to surgery.
- Has sufficient organ function including (1) Blood routine: NE≥1.5×109/L; PLT≥100×109/L; HGB≥90 g/L (2)Comprehensive Metabolic Panel: bilirubin≤ 1.5×ULN; ALT≤2.5×ULN; AST≤2.5×ULN; sCr≤1.5×ULN or CrCl≥50...
- Women of childbearing age must undergo a serological pregnancy test within 72 hrs before first administration. Women of childbearing age, or male people with childbearing age female partners, must take contraceptive...
- Good compliance, willing to comply with follow-up schedules.
- 1.people have received or are receiving any of:
- anti-tumor interventions such as radiotherapy, chemotherapy, immunotherapy or other medictions.
- Received systemic corticosteroid therapy (prednisone equivalence\> 10mg/d) or other immunosuppressive agents within the first 2 weeks prior to the first administration.
- live vaccine within 4 weeks before the first administration. 2\. Cancer related exclusion criteria
- other cancers instead of ESCC
- non-recetable or metastatic ESCC
- not comply with T1N1-3M0 or T2-3N0-3M0 (AJCC 8th).
- people with other malignant tumors within 5 years before the first administration, but people with cervical carcinoma in situ, skin basal cell carcinoma, skin squamous cell carcinoma, and localized prostate cancer...
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, 76 years and older. 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.