Esophageal Squamour Cell Cancer
Conditions
Brief summary
The goal of this Phase 2 clinical trial is to learn if the combination of Camrelizumab and Palbociclib is a safe and effective treatment when given before surgery (neoadjuvant therapy) for patients with esophageal squamous cell carcinoma (ESCC) that can be surgically removed. Camrelizumab is an immunotherapy drug that helps the immune system fight cancer, and Palbociclib is a targeted therapy drug that stops cancer cells from growing. The main questions it aims to answer are: Is the combination of Camrelizumab and Palbociclib safe for patients to receive before their surgery? How effective is this treatment combination in shrinking tumors prior to surgery?
Interventions
DRUGCamrelizumab
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.
DRUGPalbociclib
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.
Sponsors
West China Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Pathologic Response | up to 15 weeks | Major Pathologic Response (MPR) was defined as fewer than 10% viable tumor cells. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pathological Complete Response (PCR) | up to 15 weeks | The pCR will be defined as the proportion of participants with absence of residual tumor in the resected primary tumor and all resected lymph nodes after completion of neoadjuvant treatment. |
| Overall survival (OS) | Up to 2 years | Proportion of participants who achieve survival post treatment |
| Objective response rate (ORR) | up to 15 weeks | Proportion of participants with measurable disease at baseline and have been re-evaluated after at least 1 cycle of therapy with observed reduction in tumor burden as defined by RECIST and iRECIST criteria after 2 doses of Proportion of participants with measurable disease at baseline and have been re-evaluated after at least 1 cycle of therapy with observed reduction in tumor burden as defined by RECIST and iRECIST criteria after 2 doses of camrelizumab and palbociclib |
| R0 resection rate | up to 15 weeks | This will be defined as the proportion of participants with R0 resection |
| Incidence of Treatment-Emergent Adverse Events | from the first dose to within 30 days after the last dose | Number of participants who experience grade 1 or higher adverse events, as defined by Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0) |
Contacts
Primary ContactJin Zhou
Outcome results
None listed