Personalized neoantigen vaccine combined with radiotherapy for advanced tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness and safety of an individualized tumor neoantigen peptide vaccine in combination with radiotherapy for patients with advanced malignant solid tumors that have not responded to standard treatments. Patients will undergo tumor tissue collection and genomic analysis to identify specific neoantigens, which will then be used to create a personalized vaccine. The study will monitor tumor burden, immune response, and patient survival following treatment. The approach involves a multi-step process including sequencing, neoantigen prediction, and validation by multiple teams to ensure accuracy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. male or female
2. age\>18 years old
3. with advanced or recurrent malignancies diagnosed by pathology and imaging, who have failed systemic standard therapy or disease progression prior to enrollment and have no effective first-line therapy (for effective therapy, refer to the latest version of the treatment guidelines published by the Chinese Society of Clinical Oncology)
4. have at least one imaging measurable lesion
5. with an expected survival of ≥ 3 months
6. with an ECOG (Eastern Cooperative Oncology Group) score of 0-2
7. have access to sufficient tumor DNA (circulating tumor DNA or tissue samples) for analysis, or have genomic/exonic/transcriptional data from tumor and normal tissues and the data meet the analysis requirements, qualified for tumor neoantigen screening, or have prepared neoantigen peptides from a certified company (GMP)
8. women of childbearing age should have negative pregnancy tests within 7 days prior to enrollment, and have no short-term plans to have children and are willing to take protective measures (contraception or other birth control methods) before and during the clinical trial
9. compliant patients who is and able to follow the study protocol and the follow-up procedures

Exclusion Criteria:

1. No neoantigens detected in the sequencing data.
2. with a history of bone marrow or stem cell transplantation
3. enrolled in other therapeutic clinical trials; clinical trials of Chinese medicine
4. with active bacterial or fungal infections
5. with active HIV (human immunodeficiency virus, human immunodeficiency virus), HCV (hepatitis C virus), HBV (hepatitis B virus), or the herpes virus (except for crusting for more than 4 weeks), or with respiratory viral infections (except for those who have been cured for more than 4 weeks)
6. with asthma, autoimmune disease, immunodeficiency
7. under treatment with immunosuppressive drugs
8. with severe coronary or cerebrovascular disease, or other conditions that concerns the investigator for enrollment
9. have clinical, psychological or social factors affecting informed consent or study implementation
10. have a history of drug or peptide allergy, or allergy to other potential immunotherapies
11. no decision making capacity for civil conduct

Where it's running

• University of Hong Kong-Shenzhen Hospital
  Shenzhen, Guangdong, China Recruiting
• University of Hong Kong-Shenzhen Hospital
  Shenzhen, guangzhou, China Enrolling by invitation

Study contacts

• Principal investigator: Clinical Cancer Center Hong Kong University Shenzhen Hospital — Municipal hospitals
• Study coordinator: Feng-Ming (Spring) Kong
• Email: Kong001@hku.hk
• Phone: 18807550703

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• GW01-200 tablets in people with advanced cancers

  This early-phase study tests GW01-200 tablets in adults with advanced solid tumors or blood cancers to see if they are safe and how they behave in the body.

  Recruiting at 3 sites Phase 1 Groovy Medicine (Hangzhou) Ltd. · Beijing, Beijing Municipality and 2 other locations · NCT07629258

• SIBP-A10 injection for adults with advanced malignant tumors

  This trial will test whether SIBP-A10 injections are safe and tolerable and to identify the best dose for adults with advanced metastatic tumors.

  Recruiting Phase 1 Shanghai Institute Of Biological Products · Dalian, Liaoning · NCT07205198

• AL58805 treatment for people with advanced solid tumors.

  This Phase I dose-escalation trial will test different oral doses of AL58805 in people with advanced solid tumors who have exhausted standard treatment options.

  Recruiting Phase 1 Advenchen Laboratories, LLC · Changsha, Hunan · NCT07179081

• Testing MDX2004 at increasing doses in adults with advanced tumors

  This will test whether different doses of the experimental drug MDX2004 are safe and can shrink tumors in adults with advanced or metastatic cancer.

  Recruiting at 6 sites Phase 1/2 ModeX Therapeutics, An OPKO Health Company · Liverpool, New South Wales and 5 other locations · NCT07110584

• Evaluating CS23546 for patients with advanced tumors

  This study is testing a new treatment called CS23546 to see if it's safe and how well it works for people with advanced tumors.

  Recruiting Phase 1 Chipscreen Biosciences, Ltd. · Guangzhou · NCT06245122

• CG-7321: a first-in-human test in advanced solid tumors

  We’re testing CG-7321 alone and with fulvestrant to see if it’s safe and tolerable in adults with advanced solid tumors.

  Recruiting at 4 sites Phase 1 Chengdu Cynogen Bio-pharmaceutical Tech. Co., Ltd. · Fuzhou, Fujian and 3 other locations · NCT07923214

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.