Biliary Cancer (Cholangiocarcinoma, Gall Bladder Cancer)Phase 1NCT07594964
To Evaluate the Safety, Tolerability, and Preliminary Efficacy of XH001 Injection as Adjuvant Therapy in Patients With High-risk Recurrent Solid Tumors
A Phase 1 study testing XH001 Injection and mFOLFIRINOX Treatment Regimen in people with Biliary Cancer (Cholangiocarcinoma, Gall Bladder Cancer) and Pancreatic Ductal Adenocarcinoma (PDAC), run by Shenzhen Xinhe Biomedical at 2 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Biliary Cancer (Cholangiocarcinoma, Gall Bladder Cancer), Pancreatic Ductal Adenocarcinoma (PDAC), Hepatocellular Carcinoma (HCC)
- What is being tested?
- XH001 Injection and mFOLFIRINOX Treatment Regimen
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesChina
- Study dates
- 25 Aug 2025to 30 Jun 2030
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
Show all 14Show fewer
- 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;
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing
Ding yan Cao, 86-10-69156874, caodingyan@pumch.cn
Wenmin Wu, Prof.
- Recruiting
Peking University Cancer Hospital
Beijing
Changsong Qi, 0086-10-88196561, linshenpku@163.com
Lin Shen, Prof.
About this study
Official title: Phase I Clinical Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of XH001 Injection as Adjuvant Therapy in Patients With High-risk Recurrent Solid Tumors After Radical Surgery
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?
- Conditions
- Biliary Cancer (Cholangiocarcinoma, Gall Bladder Cancer), Pancreatic Ductal Adenocarcinoma (PDAC), Hepatocellular Carcinoma (HCC), Gastric Cancer (GC)
- Being tested
- XH001 Injection, mFOLFIRINOX Treatment Regimen
- Keywords
- mRNA, Neoantigen specific tumor vaccine
- Medical subject headings
- Biliary Tract Neoplasms, Cholangiocarcinoma, Gallbladder Neoplasms, Carcinoma, Hepatocellular, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XH001 InjectionBiological
mRNA neoantigen cancer vaccine
mFOLFIRINOX Treatment RegimenDrug
oxaliplatin+lrinotecan+calcium folinate+5-FU
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | XH001 injection administered based on adjuvant chemotherapy with the mFOLFIRINOX regimen Receives: Biological: XH001 Injection; Drug: mFOLFIRINOX Treatment Regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event
Incidence and severity of adverse events (AEs), clinically significant abnormal changes in laboratory tests and other examinations (based on the Criteria for the Evaluation of Adverse Events [CTCAE] v5.0)
Measured: up to 36 months
Dose-Limiting Toxicity
Grade 3 or higher adverse events (AEs) or laboratory abnormalities related to XH001 injection
Measured: From the first administration of XH001 to 4 weeks after the first administration of XH001 injection.
Immune response at different doses
Using in vitro ELISPOT and/or TCR-Clone track to verify the immunoreactivity of the peripheral blood lymphocytes from the subjects to the selected tumor neoantigens.
Measured: From Baseline up to 2 years.
Secondary outcomes (4)
Recurrent-Free Survival
The time from the patient undergoing radical surgery to recurrence or death from any cause, whichever comes first.
Measured: 3 years
Local Recurrent-Free Survival
The time from the patient undergoing radical surgery to local recurrence or death from any cause, whichever comes first.
Measured: 3 years
Distant metastasis-Free Survival
The time from the patient undergoing radical surgery to distant metastasis or death from any cause, whichever comes first. If the patient has not developed metastasis by the end of the study, the last follow-up time will be the endpoint.
Measured: 3 years
Overall survival
The time from the patient undergoing radical surgery to death from any cause.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start25 Aug 2025
- Primary completion30 Oct 2029 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Cancer (Cholangiocarcinoma, Gall Bladder Cancer)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Xinhe Biomedical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07594964
- Sponsor's protocol ID
- XH001-01
- Status last verified
- May 2026
- First submitted
- 11 May 2026
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided