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The goal of this clinical trial is to evaluate the effectiveness and safety of hyperthermic intraperitoneal chemotherapy combined with intravenous chemotherapy in peritoneal metastatic pancreatic cancer. The main question it aims to answer are:
(1) Does this combined approach increase 1-year survival rates? and (2) What is the safety profile of this treatment regimen?
Participants will:
undergo baseline imaging and surgical exploration to confirm peritoneal metastasis, receive two cycles of intraperitoneal cisplatin HIPEC (70mg/m²) postoperatively, followed by systemic AG chemotherapy (nab-paclitaxel plus gemcitabine), with treatment adjustments based on regular imaging assessments and multidisciplinary team (MDT) recommendations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIPEC + AG Chemotherapy Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with Cisplatin + Systemic AG Chemotherapy | Combination Product |
|
| Measure | Description | Time Frame |
|---|---|---|
| 1-year Overall Survival (OS) Rate | The proportion of patients alive at 12 months after initiation of the combined HIPEC and systemic AG chemotherapy treatment, analyzed by Kaplan-Meier method. | From enrollment to 12 months post-treatment initiation |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | Time from treatment initiation to radiographic disease progression (per RECIST 1.1) or death from any cause, whichever occurs first, assessed by blinded independent central review (BICR). | From enrollment until first documented progression or death (up to 24 months) |
| Objective Response Rate (ORR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenquan Wang, Dr | Contact | 86 13701874954 | wang.wenquan@zs-hospital.sh.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Xiangya Hospital of Central South University | Not yet recruiting | Changsha | Hunan | 410000 | China |
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|
Proportion of patients achieving complete response (CR) or partial response (PR) per RECIST 1.1 criteria during the study intervention period. |
| From enrollment until end of treatment (up to 12 months) |
| Safety and Tolerability (CTCAE v5.0) | Frequency and severity of adverse events (AEs), serious AEs (SAEs), and treatment discontinuations due to AEs, graded by CTCAE v5.0 | From first HIPEC cycle to 30 days after last treatment (up to 13 months) |
| Zhongshan Hospital, Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
|
| ID | Term |
|---|---|
| D000084262 | Hyperthermic Intraperitoneal Chemotherapy |
| ID | Term |
|---|---|
| D017024 | Chemotherapy, Adjuvant |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D006979 | Hyperthermia, Induced |
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