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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?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Camrelizumab+Palbociclib(100mg) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major Pathologic Response | Major Pathologic Response (MPR) was defined as fewer than 10% viable tumor cells. | up to 15 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pathological Complete Response (PCR) | 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. | up to 15 weeks |
| Overall survival (OS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jin Zhou | Contact | +8613880626596 | zhoujin096@scu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jin Zhou | West China Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| C500026 | palbociclib |
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| Palbociclib | Drug | 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. |
|
Proportion of participants who achieve survival post treatment |
| Up to 2 years |
| Objective response rate (ORR) | 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 | up to 15 weeks |
| R0 resection rate | This will be defined as the proportion of participants with R0 resection | up to 15 weeks |
| Incidence of Treatment-Emergent Adverse Events | 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) | from the first dose to within 30 days after the last dose |