XH001 Injection for High-risk Recurrent Solid Tumors
To Evaluate the Safety, Tolerability, and Preliminary Efficacy of XH001 Injection as Adjuvant Therapy in Patients With High-risk Recurrent Solid Tumors
Recruiting
Phase 1Interventional Study
Biliary Cancer (Cholangiocarcinoma, Gall Bladder Cancer)Pancreatic Ductal Adenocarcinoma (PDAC)Hepatocellular Carcinoma (HCC)Gastric Cancer (GC)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 70
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
48 (estimated)
Sponsor
Shenzhen Xinhe Biomedical · Industry
Who this trial is looking for
This trial is looking for patients with certain high-risk cancers who have had surgery. Participants will receive a new treatment combined with standard care to see how well it works and if it's safe.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 70 years old.
I have high-risk recurrent solid tumors after surgery.
I expect to live at least 12 more months.
My overall health status is classified as ECOG 0-1.
My blood cell counts meet the required levels.
I have signed and dated the informed consent form.
You may not be able to join if
I have evidence of tumor return or spread.
I have had liver issues like hepatic encephalopathy.
I have uncontrolled fluid buildup that needs treatment.
I had a stroke in the last 6 months.
I have had a heart attack or severe heart problems in the last 6 months.
I have certain types of pancreatic or biliary cancers that are not eligible.
I have an active severe infection.
I have a history of autoimmune diseases.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
The goal of this interventional clinical study is to learn the safety and preliminary efficacy of XH001 injection (Personalized mRNA tumor neoantigen vaccine) combined with standard adjuvant treatment in treating patients with high-risk recurrent solid tumors after radical surgery.
The main questions it aims to answer are: What medical problems do participants have when using the combined treatme…
The goal of this interventional clinical study is to learn the safety and preliminary efficacy of XH001 injection (Personalized mRNA tumor neoantigen vaccine) combined with standard adjuvant treatment in treating patients with high-risk recurrent solid tumors after radical surgery.
The main questions it aims to answer are: What medical problems do participants have when using the combined treatment? Does XH001 injection combined with standard adjuvant treatment induce a specific T-cell response, and can it prolong the patient's relapse-free survival?
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Provision of signed and dated informed consent form;
* Aged between 18 and 70 years old, male or female;
* Patients with high-risk recurrent solid tumors confirmed by pathology after radical surgery mainly include pancreatic ductal adenocarcinoma, biliary tract malignancies, h…
Inclusion Criteria:
* Provision of signed and dated informed consent form;
* Aged between 18 and 70 years old, male or female;
* 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.
* Expected survival duration ≥12 months;
* ECOG score of 0-1;
* White blood cell count≥ 3.0×10\^9/L; Neutrophil count ≥ 1.0×10\^9/L; Platelet count ≥75×10\^9/L; Hemoglobin (Hb)≥ 90g/L; Creatinine clearance rate≥50mL/min \[calculated using the Cockcroft-Gault formula\]; Alanine aminotransferase ≤ 3×ULN (patients with hepatocellular carcinoma or biliary tract malignancy \<5×ULN); Aspartate aminotransferase ≤ 3×ULN ((patients with hepatocellular carcinoma or biliary tract malignancy \<5×ULN); Total bilirubin ≤ 3×ULN; Serum albumin \> 28g/L; Coagulation: Prothrombin time prolongation ≤ 4s;
Exclusion Criteria:
* There is evidence of tumor residue, recurrence or metastasis during screening;
* Has a history of hepatic encephalopathy or liver transplantation;
* Has clinical uncontrolled (requiring repeated drainage) pericardial effusion, pleural effusion and moderate or severe ascites;
* Requires long-term systemic administration of antiallergic drugs, or has severe hypersensitivity reactions (\>=Grade 3) to XH001 injection and/or any of its excipients;
* New cerebrovascular accidents within 6 months before screening (including ischemic stroke, hemorrhagic stroke and transient ischemic attack);
* 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;
* Patients with pancreatic ductal adenocarcinoma (PDAC) 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;
* 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;
* .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;
* Patients with gastric adenocarcinoma have the following conditions: severe postoperative complications (severe postoperative infection, anastomotic leakage and gastrointestinal bleeding);
* Have active or poorly controlled severe infections;
* .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;
* Any history of autoimmune diseases (regardless of whether they are currently active),;
* Who have previously received similar therapeutic tumor vaccines;
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