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New treatment option for Neoadjuvent
Official title Neoadjuvant Therapy for Stage II-IVA Resectable Esophageal Squamous Cell
ClinicalTrials.gov ID: NCT06006650
What this study is testing
What is Pembrolizumab, Albumin Paclitaxel, 5-fluorouracil, Cisplatin?
Pembrolizumab, Albumin Paclitaxel, 5-fluorouracil, Cisplatin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for neoadjuvent.
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 aim of this study was to investigate the efficacy and safety of pembrolizumab combined with albumin paclitaxel and cisplatin versus albumin paclitaxel and cisplatin or 5-fluorouracil and cisplatin in neoadjuvant therapy for stage II-IVa resectable esophageal squamous cell carcinoma. The study plans to enroll 114 eligible patients who will be randomly assigned in a 1:1:1 ratio to receive 3 cycles of neoadjuvant immunochemotherapy (pembrolizumab plus albumin paclitaxel and cisplatin;Pembrolizumab plus 5-fluorouracil and cisplatin) or chemotherapy alone (5-fluorouracil and cisplatin), followed by surgery 3 weeks later, followed by 16 cycles of adjuvant immunotherapy (pembrolizumab).Patients were followed up for efficacy and safety during treatment.Tumor evaluation will be performed at screening, after neoadjuvant therapy, before surgery, and after adjuvant therapy until objective disease progression is confirmed.
- 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
- 1.Pathological diagnosis: esophageal squamous cell carcinoma. 2.18-75 years old; 3.Clinical stage II-IVa; 4.no prior antitumor therapy, such as...
You likely can't join if
- Pathological findings suggest compound squamous cell carcinoma, including squamous adenocarcinoma, squamous cell carcinoma, carcinosarcoma...
- History of subtotal gastrectomy;
- accompanied by a second primary cancer;
- Tumor metabolic imaging prior to treatment suggested distant metastasis.
- people who have previously received chemoradiotherapy;
- preesophageal perforation signs
See the full eligibility criteria
- 1.Pathological diagnosis: esophageal squamous cell carcinoma. 2.18-75 years old; 3.Clinical stage II-IVa; 4.no prior antitumor therapy, such as immunotherapy or chemoradiotherapy; 5.ECOG PS score 0-1. 6.Organs function...
- Pathological findings suggest compound squamous cell carcinoma, including squamous adenocarcinoma, squamous cell carcinoma, carcinosarcoma, sarcomatoid carcinoma, etc.
- History of subtotal gastrectomy;
- accompanied by a second primary cancer;
- Tumor metabolic imaging prior to treatment suggested distant metastasis.
- people who have previously received chemoradiotherapy;
- preesophageal perforation signs
- pregnant women of reproductive age;
- Any active autoimmune disease or a history of autoimmune disease (such as autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism...
- People with the following active infectious diseases, including active tuberculosis, hepatitis, and known human immunodeficiency virus (HIV) infection;
- Someone who has a known or concomitant hemorrhagic disease or other uncontrollable disease that cannot be treated surgically;
- Physical examination or clinical trial findings that researchers believe could interfere with the outcome or put the patient at increased risk of treatment complications;
- A previous history of interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis requiring hormone therapy, or any clinically documented active interstitial lung disease, and the presence of...
- unstable systemic diseases (active infection, moderately severe chronic obstructive pulmonary disease (copd), poorly controlled hypertension, unstable angina and congestive heart failure, 6 months occurrence of...
- Gastrointestinal dysfunction, malabsorption syndrome, active gastrointestinal ulcers;
- Previously treated with anti-PD-1 or anti-PD-L1 antibodies;
- Receiving any investigational drug within 4 weeks before the first use of the investigational drug;
- Enroll in another clinical study at the same time, unless it's an observational (non-intervention) clinical study or an intervention clinical study follow-up;
- people who require systematic treatment with corticosteroids (equivalent dose of prednisone \> 10 mg per day) or other immunosuppressive agents within 2 weeks prior to the first use of the study drug, except for the use...
- People who have been vaccinated with anti-tumor vaccine or who have been vaccinated with live vaccine within 4 weeks prior to the first administration of the study drug;
- Major surgery or severe trauma within 4 weeks before the first use of the study drug;
- Congenital or acquired immunodeficiency disease or a history of organ transplantation;A history of allergies to monoclonal antibodies, albumin paclitaxel, 5-fluorouracil, cisplatin, and other platinum-based drugs
The study team makes the final eligibility decision.
Where it's taking place
- Xi'an, Shaanxi, China
- Xi’an, Shanxi, China
- Xi'an, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 Xi'an, Shaanxi, China; Xi’an, Shanxi, China; Xi'an, 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.