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To preliminarily evaluate whether there is a survival benefit of surufatinib combined with camrelizumab and mFOLFOX6 as the second-line treatment for advanced pancreatic cancer, and to explore the feasibility of second-line and post-line treatment for advanced pancreatic cancer
Second-line clinical study of surufatinib in combination with Caralizumab advanced pancreatic cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Surufatinib in combination with Camrelizumab and mFOLFOX6 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surufatinib 250mg/d qd once daily | Drug | mFOLFOX6( Oxaliplatin + Leucovorin + fluorouracil) Oxaliplatin 85mg/m2 d1+CF 400mg/m2 d1+5-FU 400mg/m2d1 /2400mg/m2 continuous intravenous injection (civ) for 46h, The drug is administered every 14 days for a total of 8-12 cycles. |
| Measure | Description | Time Frame |
|---|---|---|
| objective response rate (ORR) | Defined as percentage of participants achieving assessed complete response (CR) and partial response (PR) by the investigator according to the RECIST 1.1. | Time Frame: up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| disease control rate (DCR) | DCR was defined as the percentage of participants who have a confirmed complete response(CR) or partial response(PR) or stable disease(SD) per RECIST 1.1 as assessed by investigator | Time Frame: up to 24 months |
| Progression-Free Survival (PFS) |
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Inclusion Criteria:
Exclusion Criteria:
Participated in other anti-tumor drug clinical trials within 28 days;
Have previously received any anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody or anti-cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) antibody or acted on T cell costimulation or checkpoints Treatment with any other antibodies of the pathway (such as OX40, CD137, etc.);
Have previously received anti-vascular endothelial growth factor/vascular endothelial growth factor receptor (VEGF/VEGFR) targeted drug treatment;
Those who are known to be allergic to any of the drugs in the study;
Brain metastasis accompanied by symptoms or symptom control time <2 months;
The subject has suffered from other malignant tumors in the past or at the same time within 5 years (except cured basal cell carcinoma of the skin and cervical cancer in situ);
Insufficient bone marrow hematopoietic function (without blood transfusion within 14 days):
Liver abnormalities:
Kidney abnormalities:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rui Hua Xu, MD | Contact | 13922206676 | xurh@sysucc.org.cn | |
| Hui Yan Luo, DR | Contact | 13719459226 | luohy@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Rui Hua Xu, MD | Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SunYat-senUniversity Cancer Center | Guangzhou | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 12, 2023 | Mar 18, 2024 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 12, 2023 | Mar 18, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| C000717729 | surufatinib |
| C000631724 | camrelizumab |
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|
PFS is defined as the time from enrollment to the first documented disease progression or death due to any cause, whichever occurs first. Responses are according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by investigator |
| Time Frame: up to 24 months |
| overall survival (OS) | OS is the time from enrollment to death due to any cause. | Time Frame: up to 24 months |
| quality of life (QoL) | Assessing the quality of life of cancer patients by QLQ-C30 | Time Frame: up to 24 months |
| adverse events (AE) | overall incidence of adverse events (AE); incidence of grade 3 or higher AE; incidence of severe adverse events (SAE); incidence of AEs leading to discontinuation of drug use; incidence of AEs leading to suspension of drug use. | Time Frame: up to 24 months |