Pancreatic ductal adenocarcinoma, Biliary tract malignancies, Hepatocellular carcinoma, Gastric adenocarcinoma
Conditions
Interventions
Dose escalation 100µg group:For subjects in the XH001 injection 100 µg dose group, according to the dose-limiting toxicity (DLT) monitoring principle, if no DLT is observed in the first 3 subjects, 3
Dose escalation 200µg group:If 1 out of the first 3 subjects in the 100 µg dose group of XH001 injection experiences a DLT, an additional 3 subjects will be enrolled in the 100 µg dose group. Once all
Dose expansion 100µg group:XH001 100ug injection
Dose expansion 200µg group:XH001 200ug injection
Sponsors
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Provision of signed and dated informed consent form; 2.Aged between 18 and 70 years old, male or female; 3.Patients with high-risk recurrent solid tumors confirmed by pathology after radical surgery mainly include pancreatic ductal adenocarcinoma, biliary tract malignancies, hepatocellular carcinoma, gastric adenocarcinoma, etc. 1) Pancreatic ductal adenocarcinoma: a) Histologically or cytologically confirmed pancreatic ductal adenocarcinoma; b) Postoperative pathological stage T1-3, N0-2, M0; c) Complete tumor resection (R0 or R1 resection); d) Recovered well from surgery: no severe nausea or vomiting; 2) Biliary tract malignancies: a) Histologically confirmed biliary tract malignancies (including intrahepatic or extrahepatic/hilar cholangiocarcinoma or muscle-invasive gallbladder cancer or distal cholangiocarcinoma), excluding the hepatocellular carcinoma-biliary cell mixed pathological type; b) Must undergo radical surgery, and complete tumor resection (R0 or R1); c) The tumor does not invade major blood vessels (hepatic artery, portal vein, superior mesenteric artery, etc.); d) The number of lymph nodes dissected during surgery is greater than 6, and there are positive lymph nodes (N+). 3) Hepatocellular carcinoma: a) Pathologically diagnosed as hepatocellular carcinoma (histological or cytological), and received radical resection or ablation (only RFA or MWA). Combined treatment is not allowed (except for one TACE after resection), and multiple treatment modalities such as resection and ablation are not allowed. Patients may receive a second ablation surgery if it is part of the initial treatment plan and not due to disease recurrence after the first surgery. If there are more than one ablation procedures, the time between the first and second ablation procedures should not exceed one week; b) For surgical patients, pathological confirmation of R0 resection is required; c) For ablation patients (only RFA or MWA), there must be complete radiological response evidence, including the disappearance of intratumoral arterial enhancement in all ablated lesions; d) No major vascular invasion of the portal vein (Vp3 or Vp4), and no major vascular invasion of the hepatic vein or inferior vena cava [resection patients with mild vascular invasion of the portal vein (Vp1 or Vp2) found by imaging or pathology are allowed to be included]; e) No extrahepatic spread confirmed by CT or MRI scans of the chest, abdomen, pelvis, and head during the screening period. f) Patients with high-risk of recurrence of hepatocellular carcinoma: Surgical patients: · No more than 3 tumors, with the largest tumor diameter > 5 cm, (without microvascular invasion or minor portal vein invasion - Vp1/Vp2), or poorly differentiated tumors (grade 3 or 4); · 4 or more tumors, with the largest tumor diameter 2 cm and <= 5 cm; · Up to 4 tumors, all <= 5 cm; g) Patients who received postoperative TACE, fully recovered within 4 weeks before ra
Exclusion criteria
Exclusion criteria: 1.There is evidence of tumor residue, recurrence or metastasis during screening; 2.Has a history of hepatic encephalopathy or liver transplantation; 3.Has clinical uncontrolled (requiring repeated drainage) pericardial effusion, pleural effusion and moderate or severe ascites; 4.Requires long-term systemic administration of antiallergic drugs, or has severe hypersensitivity reactions (>=Grade 3) to XH001 injection and/or any of its excipients; 5.New cerebrovascular accidents within 6 months before screening (including ischemic stroke, hemorrhagic stroke and transient ischemic attack); 6.Individuals who have experienced acute myocardial infarction, or have uncontrolled angina pectoris, uncontrolled arrhythmia, severe heart failure (NYHA heart failure classification standard>= Grade III) and other cardiovascular diseases within 6 months before screening; 7.Patients with pancreatic ductal adenocarcinoma (PADC) have the following conditions: 1) Borderline resectable pancreatic ductal adenocarcinoma; 2) Tumor tissue containing neuroendocrine tumor components (i.e., mixed type); 3) Pancreatic tumor types other than PDAC; 4) Persistent severe diarrhea after surgery; 8.Patients with biliary tract malignancy have the following conditions: 1) Pancreatic or ampullary cancer; 2) Unresolved biliary obstruction; 3) Insufficient surgical biliary drainage, and there are signs of infection; 9.Subjects with hepatocellular carcinoma exhibit the following conditions: 1) The tumor contains components such as fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, and biliary tract malignancy; 2) Received more than one cycle of adjuvant TACE after surgery or ablation; 10.Patients with gastric adenocarcinoma have the following conditions: severe postoperative complications (severe postoperative infection, anastomotic leakage and gastrointestinal bleeding); 11.Have not fully recovered from the surgery; 12.Suffer from skin diseases that may prevent the intradermal injection from reaching the target area (such as psoriasis); 13.Have active or poorly controlled severe infections; 14.During the screening period, virological tests show positive for human immunodeficiency virus antibodies, hepatitis B surface antigen and/or hepatitis B core antibody with hepatitis B virus DNA > 1000 IU/ml, positive for hepatitis C virus antibodies, and positive for Treponema pallidum specific antibodies; 15.Hypertension that is poorly controlled despite treatment (defined as systolic blood pressure >= 160 mmHg and/or diastolic blood pressure >= 100 mmHg); 16.Patients with other malignancies within 5 years before enrollment, except for those with a history of appropriately treated and cured cervical carcinoma in situ, breast carcinoma in situ, or skin basal cell carcinoma; 17.Any history of autoimmune diseases (regardless of whether they are currently active), including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, granulomatosis with polyangiitis, Sjögren's syndrome, Guillain-Barré syndrome, or multiple sclerosis, except for patients with a history of autoimmune-related hypothyroidism who are currently taking thyroid replacement hormones and patients with type 1 diabetes controlled well by insulin; 18.Subjects with a history of contrast agent allergy that require glucocorticoids as prophylaxis for allergic reactions during
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immune response at different doses;Safety;DLT; | — |
Secondary
| Measure | Time frame |
|---|---|
| Recurrent Free Survival (RFS);Distant metastasis Free Survival (DMFS);Local Recurrent Free Survival (LRFS);OS rate;RFS rate;Overall survival (OS); | — |
Countries
China
Contacts
Public ContactWenming Wu
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed