Tislelizumab Combined with Chemotherapy and All Trans Retinoic Acid for Locally Advanced or Metas… (NCT06703047) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Tislelizumab Combined with Chemotherapy and All Trans Retinoic Acid for Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma
180 participantsStarted 2024-11-20
Plain-language summary
Tislelizumab combined with chemotherapy and all trans retinoic acid for locally advanced or metastatic esophageal squamous cell carcinoma: a prospective, double-blind, multicenter, randomized controlled phase II trial
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. The subjects voluntarily participate and sign a written informed consent form;
. Age ≥ 18 years old;
. Diagnosed by pathological histology as an inoperable locally advanced or metastatic esophageal squamous cell carcinoma patient;
. According to AJCC 8th edition staging and RECIST 1.1 solid tumor evaluation criteria, there must be at least one measurable lesion;
. Have not received any local or systemic anti-tumor treatment for locally advanced/metastatic esophageal squamous cell carcinoma. For patients who have received adjuvant/neoadjuvant chemotherapy, or radical radiotherapy for advanced diseases, if there is a gap of at least 6 months between disease progression or recurrence and the end of the last drug treatment, they are allowed to be included in this study;
. The main organs function is good;
. Expected survival period ≥ 3 months;
. ECOG PS score: 0-1 points;
Exclusion criteria
. Patients who have received immunotherapy;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Individuals who are allergic to the drugs or their components used in this study;
. The patient currently (within 3 months) has digestive tract diseases such as esophageal varices, active ulcers of the stomach and duodenum, ulcerative colitis, portal hypertension, or other conditions determined by the researchers that may cause gastrointestinal bleeding or perforation;
. There are small cell carcinoma, adenocarcinoma, or mixed cancer components in histology;
. Central nervous system metastasis has occurred;
. Complete esophageal obstruction;
. Unable to tolerate gastrointestinal endoscopic biopsy; Having clear concerns about gastrointestinal bleeding (such as local active ulcer lesions, positive fecal occult blood); History of gastrointestinal bleeding within 6 months;
. Patients with primary malignant tumors other than esophageal cancer (excluding cured skin basal cell carcinoma and cervical carcinoma in situ);