The Safety and Feasibility of Neoadjuvant Camrelizumab With Palbociclib for the Treatment of Resectable Esophageal Squamous Cell Carcinoma：A Phase 1 Trial
New treatment combo tested for early-stage esophageal cancer
Plain English Summary
Neoadjuvant Camrelizumab With Palbociclib for Resectable Esophageal Squamous Cell Carcinomas is a Phase 1 clinical trial sponsored by West China Hospital studying Esophageal Squamous Cell Carcinoma. This trial tests a new combination of two drugs, Camrelizumab and Palbociclib, given before surgery for esophageal squamous cell carcinoma. It is for patients with resectable (can be removed by surgery) esophageal squamous cell carcinoma. Participants will receive the study drugs before surgery and will be monitored for side effects and how well the treatment works. Standard treatment options for this condition may include surgery alone, or surgery with chemotherapy and/or radiation. The trial aims to enroll 6 participants.
Official Summary
The purpose of this study is to explore the safety and feasibility of anti-programmed cell death 1(PD-1) immunotherapy, Camrelizumab, combined with cyclin-dependent kinase 4/6 blockade, Palbociclib, as a new neoadjuvant treatment regimen for patients with resectable esophageal squamous cell carcinoma (ESCC).
Who Can Participate
Here is what you need to know about eligibility for this trial. Patients diagnosed with esophageal squamous cell cancer. The cancer must be located in the chest and considered operable by scans. Must be between 18 and 75 years old with good general health and normal organ function. Cannot have had other cancer treatments recently or have active autoimmune diseases. This trial is studying Esophageal Squamous Cell Carcinoma, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcomes measure how safe and feasible the new drug combination is, meaning researchers will track any side effects and see if the treatment can be given as planned before surgery. The specific primary outcome measures are: Safety of combination camrelizumab and palbociclib as assessed by number of participants who experience adverse events (up to 15 weeks); Feasibility of combination camrelizumab and palbociclib as assessed by number of participants who experience adverse events (up to 15 weeks). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 1, the first major stage of clinical testing. Phase 1 trials typically involve 20-100 participants and focus on safety, dosage levels, and side effects. The primary goal is not to test whether the treatment works but to establish that it is safe enough for further testing. About 70% of Phase 1 drugs advance to Phase 2. If successful, the treatment will proceed to Phase 2 efficacy testing.
Why This Trial Matters
This trial explores a novel neoadjuvant (pre-surgery) treatment combining immunotherapy and targeted therapy to potentially improve outcomes for patients with resectable esophageal squamous cell carci This research targets Esophageal Squamous Cell Carcinoma, where improved treatment options are needed.
Investor Insight
This Phase 1 trial is an early step to assess a new combination therapy for a specific type of esophageal cancer, indicating potential future market opportunities if successful, though approval probab Phase 1 trials have approximately a 10% chance of eventually gaining FDA approval.
Is This Trial Right for Me?
Ask your doctor if this combination therapy is right for you and what the potential benefits and risks are. Understand that participation involves receiving study drugs before surgery and regular medical check-ups. Be prepared for potential side effects and the need for close monitoring throughout the study. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: NON_RANDOMIZED
- Model: PARALLEL
- Masking: NONE
- Enrollment: 6 participants
Interventions
- DRUG: Camrelizumab — Camrelizumab will be given at at a dose of 200 mg intravenously on day 23 of a planned 28-day cycle, and two doses before surgery.
- DRUG: Palbociclib(100mg) — Palbociclib will be given at a dose of 100 mg every day orally with three weeks on and one week off. Four weeks is a cycle and it will be given for three cycles.
- DRUG: Palbociclib(125mg) — Palbociclib will be given at a dose of 125 mg every day orally with three weeks on and one week off. Four weeks is a cycle and it will be given for three cycles.
Primary Outcomes
- Safety of combination camrelizumab and palbociclib as assessed by number of participants who experience adverse events (up to 15 weeks)
- Feasibility of combination camrelizumab and palbociclib as assessed by number of participants who experience adverse events (up to 15 weeks)
Secondary Outcomes
- Major Pathologic Response (up to 15 weeks)
- Objective response rate (ORR) (up to 15 weeks)
- Progression free survival(PFS) (Up to 2 years)
- Overall survival (OS) (Up to 2 years)
Full Eligibility Criteria
Inclusion Criteria: * Patients diagnosed with esophageal squamous cell cancer by gastroscopic biopsies. * The primary tumor should be located in the thorax and evaluated resectable( cT1b-T3N1-3M0, cT3N0M0) by CT/MRI/EUS * The patients should be at the range of 18-75 years old, Eastern Cooperative Oncology Group (ECOG) 0-1. * The patients should have no functional disorders in major organs. Blood routine tests, as well as lung, liver, kidney, and heart functions should be basically normal. * The patients should be able to understand our research and be willing to accept surgical treatment and sign the informed consent. Exclusion Criteria: * The stage of tumor is T4b (AJCC/International Union Against Cancer (UICC) 8th Edition) and cannot be resected. * Currently undergoing other chemotherapy, radiotherapy, targeted therapy or immunotherapy. * History of other malignancies. * Have an active autoimmune disease requiring systemic treatment or a documented history of clinically severe autoimmune disease. * Any history of allergic disease, or a sever hypersensitivity reaction to drugs, or allergy to the study drug components. * Presence of serious medical diseases, such as grade II and above cardiac dysfunction (NYHA criteria), ischemic heart diseases, etc. * The patients with severe systematic intercurrent diseases, including active infection or poorly controlled diabetes, coagulation disorders, hemorrhagic tendency, or those undergoing thrombolysis or anticoagulant therapy etc. are excluded from the study. * Female participants who test positive for a serum pregnancy test, are in the lactation period, or are at a childbearing stage and unwilling to use contraception measures during the research are excluded. * Received any investigational drug within 4 weeks prior to the first dose, or concurrently enrolled in another clinical trial. * Any other factors that are not suitable for inclusion in this study judged by investigators.
Trial Locations
- West China Hospital, Sichuan University, Chengdu, Sichuan, China
Frequently Asked Questions
What is clinical trial NCT06654297?
NCT06654297 is a Phase 1 INTERVENTIONAL study titled "Neoadjuvant Camrelizumab With Palbociclib for Resectable Esophageal Squamous Cell Carcinomas." It is currently active, not recruiting and is sponsored by West China Hospital. The trial targets enrollment of 6 participants.
What conditions does NCT06654297 study?
This trial investigates treatments for Esophageal Squamous Cell Carcinoma. The primary condition under study is Esophageal Squamous Cell Carcinoma.
What treatments are being tested in NCT06654297?
The interventions being studied include: Camrelizumab (DRUG), Palbociclib(100mg) (DRUG), Palbociclib(125mg) (DRUG). Camrelizumab will be given at at a dose of 200 mg intravenously on day 23 of a planned 28-day cycle, and two doses before surgery.
What does Phase 1 mean for NCT06654297?
Phase 1 trials are the first stage of testing a new treatment in humans. They focus on safety, dosage, and side effects, usually involving 20-100 healthy volunteers or patients.
What is the current status of NCT06654297?
This trial is currently "Active, Not Recruiting." It started on 2024-10-27. The estimated completion date is 2027-02-07.
Who is sponsoring NCT06654297?
NCT06654297 is sponsored by West China Hospital. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06654297?
The trial aims to enroll 6 participants. The trial status is active, not recruiting.
How is NCT06654297 designed?
This is a interventional study, uses non_randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT06654297?
The primary outcome measures are: Safety of combination camrelizumab and palbociclib as assessed by number of participants who experience adverse events (up to 15 weeks); Feasibility of combination camrelizumab and palbociclib as assessed by number of participants who experience adverse events (up to 15 weeks). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06654297 being conducted?
This trial is being conducted at 1 site, including Chengdu, Sichuan (China).
Where can I find official information about NCT06654297?
The official record for NCT06654297 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06654297. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06654297 testing in simple terms?
This trial tests a new combination of two drugs, Camrelizumab and Palbociclib, given before surgery for esophageal squamous cell carcinoma. It is for patients with resectable (can be removed by surgery) esophageal squamous cell carcinoma.
Why is this trial significant?
This trial explores a novel neoadjuvant (pre-surgery) treatment combining immunotherapy and targeted therapy to potentially improve outcomes for patients with resectable esophageal squamous cell carci
What are the potential risks of participating in NCT06654297?
Common side effects may include fatigue, nausea, low blood cell counts, and skin reactions. More serious side effects can include severe allergic reactions, heart problems, or worsening of autoimmune conditions. The study drugs may interact with other medications, so it's important to tell your doctor about all medicines you are taking. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06654297?
Ask your doctor if this combination therapy is right for you and what the potential benefits and risks are. Understand that participation involves receiving study drugs before surgery and regular medical check-ups. Be prepared for potential side effects and the need for close monitoring throughout the study. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06654297 signal from an investment perspective?
This Phase 1 trial is an early step to assess a new combination therapy for a specific type of esophageal cancer, indicating potential future market opportunities if successful, though approval probab This is a Phase 1 trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will receive the study drugs before surgery and will be monitored for side effects and how well the treatment works. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
More Esophageal Squamous Cell Carcinoma Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.