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 1 Interventional 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.

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About This Trial
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…
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…
Contacts

Yi Zhang

0086-18615536063

yiz@neocura.net

CONTACT

Bo Liu

0086-18101388626

bliu@neocura.net

CONTACT