Combining a cancer vaccine with immunotherapy for liver cancer treatment

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

The TERTIO trial aims to evaluate the effectiveness of a novel treatment combining a CD4 Th1-inducer cancer vaccine derived from telomerase (UCPVax) with the immunotherapy agents atezolizumab and bevacizumab in patients with unresectable hepatocellular carcinoma (HCC). This phase II trial will assess the objective response rate at 6 months across 10 centers, involving a total of 105 patients. The study focuses on patients who have not previously received systemic anti-cancer treatment and have measurable disease according to established guidelines.

Why it matters

Who can join: the full rules

Main inclusion Criteria:

1. Signed informed consent
2. Histologically confirmed hepatocellular carcinoma
3. Locally advanced, metastatic, or unresectable disease
4. Patient who had not previously received systemic anti-cancer treatment
5. Age ≥ 18 years
6. Measurable disease defined according to mRECIST guidelines (Note: Previously irradiated lesions can be considered as measurable disease only if disease progression has been unequivocally documented at that site since radiation.)
7. Patients who have received previous chemoembolization, radioembolization and/or radiotherapy should have recovered from any treatment related toxicity, to a level of ≤ grade 1 (according to National Cancer Institute \[NCI\] common terminology criteria for adverse events, version 5 (CTCAE v5) with the exception of Grade 2 alopecia
8. Performance status \< 2
9. Child-Pugh Class A status
10. BCLC C stage or BCLC B stage not eligible to loco-regional therapy according to the Barcelona Clinic Liver Cancer (BCLC) staging system

Main exclusion Criteria:

Non-eligible to a clinical trial:

1. Patients previously exposed to anti-tumor immunotherapy as anti-PD-1, anti-PD-L1, or anti-CTLA4 agent or any immune therapy.
2. Diagnosis of additional malignancy within 3 years prior to the inclusion with the exception of curatively treated basal cell carcinoma of the skin and/or curatively resected in situ cervical or breast cancer
3. Patient with any medical or psychiatric condition or disease, which would make the patient inappropriate for entry into this study
4. Current participation in a study of an investigational agent or in the period of exclusion
5. Patient under guardianship, curatorship or under the protection of justice

   Cancer-specific exclusion criteria:
6. Know fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
7. Uncontrolled pleural effusion, pericardial effusion, ascites or symptomatic fistula
8. Uncontrolled tumor-related pain: exposing patients to risk of exposure to corticoids or iterative hospitalizations. Symptomatic lesions amenable to palliative radiotherapy should be treated prior to inclusion. Patients should be recovered from the effects of radiation. There is no required minimum recovery period
9. Known active central nervous system metastases and/or carcinomatous meningitis. Subject with previously treated brain metastases and with radiological and clinical stability are allowed

   Non-eligible to treatment:
10. History of encephalopathy
11. Prior bleeding event due to untreated or incompletely treated esophageal and/or gastric varices within 6 months prior to randomization
12. Inadequate organ functions: known cardiac failure of unstable coronaropathy, respiratory failure, or uncontrolled infection or another life-risk condition

Where it's running

• CHU de Besançon
  Besançon, France Recruiting
• CH William Morey
  Chalon-sur-Saône, France Recruiting
• Hôpital Henri Mondor
  Créteil, France Recruiting
• Centre Georges François Leclerc
  Dijon, France Recruiting
• Hôpital Nord Franche-Comté
  Montbéliard, France Recruiting
• CHU de Montpellier
  Montpellier, France Recruiting

Study contacts

• Study coordinator: Borg Christophe, Pr
• Email: xtoph.borg@gmail.com
• Phone: +33 3 81 47 99 99

Similar studies

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

• Carbon ion radiotherapy plus atezolizumab and bevacizumab for advanced hepatocellular carcinoma

  This trial will try adding carbon ion radiotherapy to standard atezolizumab‑bevacizumab treatment for adults with advanced hepatocellular carcinoma to see if it controls tumors better and improves survival.

  Recruiting Phase 2 Yonsei University · Seoul · NCT07246668

• Combining atezolizumab and bevacizumab with Y-90 radioembolization to help people with liver cancer get to transplant

  This trial tests whether adding immunotherapy (atezolizumab plus bevacizumab) to Y-90 radioembolization can help people with hepatocellular carcinoma bridge to or be downstaged for liver transplant.

  Recruiting Phase 4 Icahn School of Medicine at Mount Sinai · New York, New York · NCT07059494

• Preventive endoscopic banding for high-risk esophageal varices in people with hepatocellular carcinoma starting atezolizumab plus bevacizumab

  This study will test whether doing preventive endoscopic banding of high-risk esophageal varices can reduce bleeding in people with hepatocellular carcinoma who are starting atezolizumab plus bevacizumab.

  Recruiting Phase 2 Asan Medical Center · Seoul, Song-pa · NCT06819566

• Combination therapy for hepatocellular carcinoma using atezolizumab, bevacizumab, and memantine

  This study is testing a new combination of three medications to see if it can help people with advanced liver cancer feel better and improve their quality of life.

  Recruiting at 2 sites Phase 2 Inova Health Care Services · Fairfax, Virginia and 1 other locations · NCT06789757

• Combining Atezolizumab and Bevacizumab with Photon Radiotherapy for Liver Cancer

  This study is testing if combining two cancer drugs, atezolizumab and bevacizumab, with radiation therapy can help people with liver cancer that can't be surgically removed live longer and feel better.

  Recruiting Phase 2 Chang Gung Memorial Hospital · Taoyuan City, Taiwan · NCT06339424

• Valemetostat with atezolizumab and bevacizumab for advanced hepatocellular carcinoma

  This will test whether adding the oral drug valemetostat to atezolizumab and bevacizumab helps people with advanced hepatocellular carcinoma who have not received prior systemic therapy.

  Recruiting Phase 1/2 University of Alabama at Birmingham · Birmingham, Alabama · NCT06294548

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.