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New treatment option for Esophageal Squamous Cell Carcinoma (ESCC)
Official title Neoadjuvant Immunotherapy Combined With Chemotherapy Sequenced With Endoscopic Resection for Esophageal Cancer (Endosurgery-02)
ClinicalTrials.gov ID: NCT07317609
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 (escc).
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
- This single-center, prospective, single-arm study will evaluate whether giving neoadjuvant chemoimmunotherapy can safely shrink esophageal cancer and allow organ-preserving endoscopic removal in selected patients. Adults with esophageal cancer will receive at least two 3-week cycles of a PD-1 inhibitor (tislelizumab 200 mg on Day 1) plus carboplatin (AUC 3-5, Day 1) and nab-paclitaxel (≤260 mg/m², Day 1).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Cohort A - Potentially resectable ESCC: ：
- Age range: 18-80 years old;
- Patients diagnosed with esophageal squamous cell carcinoma (ESCC) through histopathological examination of biopsy tissues from the primary tumor;
- Patients with potentially resectable esophageal cancer confirmed by imaging and endoscopic examinations (T1b-3, N0, M0, with a tumor size not...
- Patients with a preoperative Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
You likely can't join if
- Patients with potential tracheoesophageal fistula or aortoesophageal fistula;
- Patients with severe malnutrition or requiring tube feeding;
- Patients with other malignancies that have not been cured within the past 2 years (except for cured basal cell carcinoma of the skin and cured...
- Patients with active autoimmune diseases or a history of autoimmune diseases or symptoms that require systemic corticosteroid treatment or...
- Immunocompromised patients, or patients who are still receiving systemic steroids (prednisone \> 10 mg/day or equivalent) or other forms of...
- Patients with active infections requiring systemic treatment within 7 days before the first neoadjuvant therapy in this study;
See the full eligibility criteria
- Cohort A - Potentially resectable ESCC: ：
- Age range: 18-80 years old;
- Patients diagnosed with esophageal squamous cell carcinoma (ESCC) through histopathological examination of biopsy tissues from the primary tumor;
- Patients with potentially resectable esophageal cancer confirmed by imaging and endoscopic examinations (T1b-3, N0, M0, with a tumor size not exceeding 5 cm and occupying less than 2/3 of the luminal circumference)...
- Patients with a preoperative Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
- Patients with a preoperative American Society of Anesthesiologists (ASA) physical status classification of I-III;
- Female patients of reproductive age should have a negative pregnancy test and be willing to use effective contraceptive methods during the study period;
- Patients who have signed the informed consent form.
- Patients with potential tracheoesophageal fistula or aortoesophageal fistula;
- Patients with severe malnutrition or requiring tube feeding;
- Patients with other malignancies that have not been cured within the past 2 years (except for cured basal cell carcinoma of the skin and cured carcinoma in situ of the cervix);
- Patients with active autoimmune diseases or a history of autoimmune diseases or symptoms that require systemic corticosteroid treatment or anti-autoimmune drug therapy;
- Immunocompromised patients, or patients who are still receiving systemic steroids (prednisone \> 10 mg/day or equivalent) or other forms of immunosuppressive therapy within 7 days before the first dose of neoadjuvant...
- Patients with active infections requiring systemic treatment within 7 days before the first neoadjuvant therapy in this study;
- Patients with a history of allogeneic organ or stem cell transplantation;
- Patients with allergies to drugs or related components involved in this study;
- Patients who are currently participating in any other clinical study. Cohort B - Surgery-contraindicated ESCC: Inclusion Criteria:
- Individuals aged above 18 years;
- Patients diagnosed with esophageal squamous cell carcinoma through histopathological examination of biopsy tissues from the primary tumor;
- Patients with esophageal cancer deemed as surgically contraindicated (including those with cervical esophageal cancer, surgical contraindications, those who refuse surgery, or those considered high-risk for...
- Patients who have not undergone any antitumor treatment, including but not limited to surgery, radiotherapy, chemotherapy, immunotherapy, and targeted therapy;
- Female patients of reproductive age should have a negative pregnancy test and be willing to adopt effective contraceptive measures during the study period;
- Patients who have signed the informed consent form. Exclusion Criteria:
- Patients with allergies to the drugs or related components involved in this study;
- Patients who are currently participating in any other clinical study.
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 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.