Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06427252
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-23
First Post:
2024-05-19
Brief Title:
The Efficacy and Safety of HIPEC Combined With PD-1 and SOX Chemotherapy for the Translational Treatment of GC or EGJC With PM
Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Organization:
The First Affiliated Hospital with Nanjing Medical University
Study Overview
Official Title:
The Efficacy and Safety of HIPEC Combined With PD-1 and SOX Chemotherapy for the Translational Treatment of Gastric or Esophagogastric Junctional Cancer With Peritoneal Metastasis A Prospective Multicenter Phase II Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Gastric cancer GC with peritoneal metastasis has a poor prognosis and short survival In recent years heat intraperitoneal perfusion chemotherapy HIPEC has gained better efficacy in the treatment of peritoneal metastases of many malignant tumors including GC with peritoneal metastasis The use of immune checkpoint inhibitors ICIs in the treatment of advanced GC has made significant progress in recent years And studies showed that patients who were responded to immunotherapy combined with chemotherapy as the first-line treatment were able to achieve significant survival benefit after radical resection However whether HIPEC combined with immunotherapy for peritoneal metastatic gastric cancer improves the R0 resection rate and prolongs survival time is currently unclear Therefore we conducted this prospective multicenter clinical trial to explore the effective dose and safety of the combination of systemic chemotherapy HIPEC anti-PD-1 and anti-HER-2 therapy which will provide a clinical basis for the treatment of advanced GC
Detailed Description:
Gastric cancer GC is the 5th most common malignant tumor worldwide and it causes the 4th most tumor-related deaths among all malignant tumors China is a large country with 40 of the total number of GC cases worldwide Despite the advances in medical detection methods most of the GC patients in China are in the advanced stage at the time of diagnosis in which peritoneal metastasis is one of the common metastatic patterns of advanced GC and the presence of peritoneal metastasis accounts for about 46 of patients with distant metastasis detected at the first diagnosis The prognosis of GC patients with peritoneal metastasis is extremely poor and compared with other metastatic organs patients with stage IV GC with peritoneal metastasis have a worse prognosis and shorter survival
The treatment of peritoneal metastasis of GC has been based on systemic chemotherapy with reference to advanced GC but it is difficult for traditional chemotherapeutic agents to reach the peritoneal lesions due to the existence of blood-peritoneal barrier In recent years heat intraperitoneal perfusion chemotherapy HIPEC has gained better efficacy in the treatment of peritoneal metastases of many malignant tumors including GCHIPEC allows chemotherapeutic drugs to act directly on tumor tissues while reducing the impact on other parts of the body the warming effect is synergistic with the antitumor effects of chemotherapeutic drugs and helps the drugs to act more efficiently on the intraperitoneal tumor cells moreover the chemotherapeutic drugs are absorbed through the peritoneum and then enter the liver via the portal vein route which is beneficial to preventing liver metastasis HIPEC currently has four applications and indications in the clinic firstly palliative application to improve the quality of life for GC abdominal metastasis with a large amount of carcinomatous ascites secondly therapeutic application of radical gastric cancer surgery cytoreductive surgery HIPEC for the treatment of GC third prophylactic application radical gastric cancer surgery peritoneal hyperthermia chemotherapy targeting people with high risk of peritoneal recurrence especially patients with T3-4 or positive lymph nodes fourth neoadjuvant application neoadjuvant chemotherapy combined with peritoneal hyperthermia chemotherapy before radical gastric cancer treatment in order to reduce the risk of peritoneal implantation of gastric cancer and to increase the possibility of radical surgery However there is a lack of high-level evidence-based medical evidence on the efficacy and safety of HIPEC as a translational treatment for GC with peritoneal metastasis
The use of immune checkpoint inhibitors ICIs in the treatment of advanced GC has made significant progress in recent years The KEYNOTE series of studies evaluated the safety and efficacy of PD-L1 antibody as a first-line treatment for advanced GC among which the results of KEYNOTE-859 confirmed that the combination of Pembrolizumab and chemotherapy is expected to be a HER-2 negative advanced gastricesophagogastric junctional cancer first-line treatment option A recent retrospective study by Chinese scholars demonstrated that patients with stage IV GC who were responded to the immunotherapy combined with chemotherapy as the first-line treatment were able to achieve significant survival benefit after radical resection However whether HIPEC combined with immunotherapy for peritoneal metastatic gastric cancer improves the R0 resection rate and prolongs survival time is currently unclear
Therefore we conducted this prospective multicenter clinical trial trying to combine the specificity of HIPEC for peritoneal metastases with immunotherapy for advanced GC aiming to evaluate the efficacy and feasibility of multimodal treatment regimens such as HIPEC in combination with immunotherapy for the transformative treatment of peritoneal metastases of GC or EJ junctional cancer and to explore the effective dose and safety of the combination of systemic chemotherapy HIPEC anti-PD-1 and anti-HER-2 therapy which will provide a clinical basis for the treatment of advanced GC
The treatment of peritoneal metastasis of GC has been based on systemic chemotherapy with reference to advanced GC but it is difficult for traditional chemotherapeutic agents to reach the peritoneal lesions due to the existence of blood-peritoneal barrier In recent years heat intraperitoneal perfusion chemotherapy HIPEC has gained better efficacy in the treatment of peritoneal metastases of many malignant tumors including GCHIPEC allows chemotherapeutic drugs to act directly on tumor tissues while reducing the impact on other parts of the body the warming effect is synergistic with the antitumor effects of chemotherapeutic drugs and helps the drugs to act more efficiently on the intraperitoneal tumor cells moreover the chemotherapeutic drugs are absorbed through the peritoneum and then enter the liver via the portal vein route which is beneficial to preventing liver metastasis HIPEC currently has four applications and indications in the clinic firstly palliative application to improve the quality of life for GC abdominal metastasis with a large amount of carcinomatous ascites secondly therapeutic application of radical gastric cancer surgery cytoreductive surgery HIPEC for the treatment of GC third prophylactic application radical gastric cancer surgery peritoneal hyperthermia chemotherapy targeting people with high risk of peritoneal recurrence especially patients with T3-4 or positive lymph nodes fourth neoadjuvant application neoadjuvant chemotherapy combined with peritoneal hyperthermia chemotherapy before radical gastric cancer treatment in order to reduce the risk of peritoneal implantation of gastric cancer and to increase the possibility of radical surgery However there is a lack of high-level evidence-based medical evidence on the efficacy and safety of HIPEC as a translational treatment for GC with peritoneal metastasis
The use of immune checkpoint inhibitors ICIs in the treatment of advanced GC has made significant progress in recent years The KEYNOTE series of studies evaluated the safety and efficacy of PD-L1 antibody as a first-line treatment for advanced GC among which the results of KEYNOTE-859 confirmed that the combination of Pembrolizumab and chemotherapy is expected to be a HER-2 negative advanced gastricesophagogastric junctional cancer first-line treatment option A recent retrospective study by Chinese scholars demonstrated that patients with stage IV GC who were responded to the immunotherapy combined with chemotherapy as the first-line treatment were able to achieve significant survival benefit after radical resection However whether HIPEC combined with immunotherapy for peritoneal metastatic gastric cancer improves the R0 resection rate and prolongs survival time is currently unclear
Therefore we conducted this prospective multicenter clinical trial trying to combine the specificity of HIPEC for peritoneal metastases with immunotherapy for advanced GC aiming to evaluate the efficacy and feasibility of multimodal treatment regimens such as HIPEC in combination with immunotherapy for the transformative treatment of peritoneal metastases of GC or EJ junctional cancer and to explore the effective dose and safety of the combination of systemic chemotherapy HIPEC anti-PD-1 and anti-HER-2 therapy which will provide a clinical basis for the treatment of advanced GC
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None