Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a Phase II, single-arm, multicentre study, assessing the efficacy and safety of durvalumab and tremelimumab with lenvatinib in participants with unresectable HCC.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental | Durvalumab and Tremelimumab with Lenvatinib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Durvalumab | Drug | Durvalumab IV (intravenous infusion) |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS) per RECIST 1.1 | Efficacy endpoint | From the date of first dose until the date of objective PD per RECIST 1.1 or death, whichever came first. It will be assessed when approximately 69 PFS events have occurred (60% maturity), approximately 8 months after the last patients dosed. |
| Measure | Description | Time Frame |
|---|---|---|
| Grade ≥ 3 TRAE within 6 months after the initiation of study intervention | safety endpoint | From first dose to 6 months after the initiation of study intervention |
| Overall Survival (OS) | Efficacy endpoint |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Beijing | 100029 | China | |||
| Research Site |
Qualified researchers can request access to anonymized individual patient- level data from AstraZeneca group of companies sponsored clinical trials via the request portal.
Plan Description: All request will be evaluated as per the Az disclosure commitment:
https://astrazenecaarouptrials.pharmacm.com/ST/Submission/Disclosure Yes. indicates that Az are accepting requests for IPD ,but this does not mean are quests will be shared
AstraZeneca will meet or exceed data availability as per the commitment at made to the EFPIA Pharma Data Sharing Principles .For details of our timeline please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool.
Signed Data Sharing Agreement(non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to a air access. For additional details. please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Tremelimumab | Drug | Tremelimumab IV (intravenous infusion) |
|
| Lenvatinib | Combination Product | Lenvatinib Oral |
|
| From the date of the first dose of study intervention until death due to any cause. It will be assessed when approximately 69 OS events have occurred (60% maturity), approximately 24 months after last participant has been assigned to study intervention. |
| Objective Response Rate (ORR) per RECIST 1.1 | Efficacy endpoint | From the date of the first dose of study intervention until the date of objective PD per RECIST 1.1. It is anticipated that this analysis will be performed approximately 8 months after the last patient has been assigned to study intervention. |
| Disease Control Rate (DCR) per RECIST 1.1 | Efficacy endpoint | From the date of the first dose of study intervention until the date of objective PD per RECIST 1.1. It is anticipated that this analysis will be performed approximately 8 months after the last patient has been assigned to study intervention. |
| Duration of response (DoR) per RECIST 1.1 | Efficacy endpoint | From the date of response until the date of objective PD per RECIST 1.1 or death, whichever came first. It is anticipated that this analysis will be performed approximately 8 months after the last patient dosed. |
| Progression Free Survival (PFS) per mRECIST | Efficacy endpoint | From the date of the first dose until the date of objective PD per mRECIST or death, whichever came first. It will be assessed when approximately 69 PFS events have occurred (60% maturity), approximately 8 months after the last patients dosed. |
| Beijing |
| 100044 |
| China |
| Research Site | Beijing | 100142 | China |
| Research Site | Chengdu | 610078 | China |
| Research Site | Chongqing | 400016 | China |
| Research Site | Guangzhou | 510060 | China |
| Research Site | Guangzhou | 510095 | China |
| Research Site | Guangzhou | 510120 | China |
| Research Site | Guangzhou | 510515 | China |
| Research Site | Hangzhou | 310022 | China |
| Research Site | Hefei | 230022 | China |
| Research Site | Jinan | 250021 | China |
| Research Site | Nanjing | 210009 | China |
| Research Site | Nanjing | 210029 | China |
| Research Site | Ningbo | 315010 | China |
| Research Site | Shanghai | 200032 | China |
| Research Site | Shanghai | 200438 | China |
| Research Site | Tianjin | 300060 | China |
| Research Site | Wenzhou | 325000 | China |
| Research Site | Wuhan | 430030 | China |
| Research Site | Xiamen | 361004 | China |
| Research Site | Zhengzhou | 450052 | China |
| Research Site | New Territories | Hong Kong |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000613593 | durvalumab |
| C520704 | tremelimumab |
| C531958 | lenvatinib |
Not provided
Not provided
Not provided