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New treatment option for Esophageal Cancer
Official title Pembrolizumab Combined With Preoperative Chemotherapy (Albumin Paclitaxel+Carboplatin) Neoadjuvant Therapy for Resectable Locally Advanced (Stage II/III) Esophageal Squamous Cell Carcinoma
ClinicalTrials.gov ID: NCT06304350
What this study is testing
What is Combination of pembrolizumab and platinum containing dual drugs?
Combination of pembrolizumab and platinum containing dual drugs 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
- This study is a prospective, single center, open label, single arm clinical study. Select resectable locally advanced (cT3-4aN0M0, cT1-3N1-2M0, cII/III stage) esophageal cancer with pathological diagnosis of squamous cell carcinoma for inclusion, receive pembrolizumab combined with platinum containing dual drug (albumin paclitaxel+carboplatin) treatment for 2 courses, and undergo surgery.
- 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
- Baseline stage resectable cII/III esophageal squamous cell carcinoma (8th UICC TNM stage);
- Failure to receive anti-tumor treatment for esophageal squamous cell carcinoma;
- Age range from 18 to 75 years old;
- There are no surgical contraindications in the preoperative evaluation of various organ functions;
- The following laboratory tests confirm that the bone marrow, liver and kidney functions meet the requirements for participating in the study...
You likely can't join if
- Individuals who have received previous treatment for esophageal cancer (surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, etc.);
- Not suitable for surgery or with surgical contraindications;
- Have a history of other anti PD-L1/PD-1 treatments;
- Individuals with immunodeficiency or long-term systemic steroid therapy, or those who have received any immunosuppressive therapy within 7 days prior...
- Individuals with active autoimmune diseases requiring systemic treatment within 2 years;
- Patients with poor control of heart disease
See the full eligibility criteria
- Baseline stage resectable cII/III esophageal squamous cell carcinoma (8th UICC TNM stage);
- Failure to receive anti-tumor treatment for esophageal squamous cell carcinoma;
- Age range from 18 to 75 years old;
- There are no surgical contraindications in the preoperative evaluation of various organ functions;
- The following laboratory tests confirm that the bone marrow, liver and kidney functions meet the requirements for participating in the study: hemoglobin ≥ 9.0g/L; White blood cell count 4.0-10 × 109/L; Neutrophil...
- Patients who have not undergone chemotherapy, radiation therapy, or hormone therapy for malignant tumors, have no history of other malignant tumors, and do not include prostate cancer patients who have received hormone...
- Expected to achieve R0 resection;
- Physical state ECOG 0-1;
- The people must understand and sign the informed consent form
- Individuals who have received previous treatment for esophageal cancer (surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, etc.);
- Not suitable for surgery or with surgical contraindications;
- Have a history of other anti PD-L1/PD-1 treatments;
- Individuals with immunodeficiency or long-term systemic steroid therapy, or those who have received any immunosuppressive therapy within 7 days prior to receiving the study drug;
- Individuals with active autoimmune diseases requiring systemic treatment within 2 years;
- Patients with poor control of heart disease
- Pregnant or lactating female patients;
- For patients with drug allergies in the protocol. Exit criteria： Withdrawal cases refer to people who have stopped continuing treatment in clinical research due to various reasons. people who experience the following...
- The main indicators are missing, and more than half of the items that can be filled in CRF are missing;
- The surgical procedure violates the plan;
- Cases that are excluded due to adverse reactions are not evaluated for how well it works, but side effects should be included in the statistics;
- According to the researcher's opinion, continuing to participate in the study will be harmful to their health;
- Patients who fail to undergo non-surgical treatment due to various reasons, including malignant tumor progression, underlying disease progression, patient or their trustee requesting withdrawal, will be reported...
- Missing people. All people who withdrew from the study should record their reasons for withdrawal in the CRF and their medical records. According to the ITT principle, all withdrawn cases should undergo survival...
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.