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Lay Description

We propose to test whether H1 and H2 clustering can distinguish patients responsive or resistant to the combination therapy with immunotherapy in a prospective clinical study.

Category

  • Cancers and Other Neoplasms
  • Immune System
IRB Number
20220298HU
NCT Number
ct.gov registration not required
Open to Enrollment
Yes

Eligibility

Eligible Ages
18 and over
Eligible Genders
All
Accepts Healthy Volunteers

Inclusion Criteria

1. Patients with HCC who are not candidates for curative or locoregional treatments .

2. Patients who are candidates to receive first-line immunotherapy-based regimens (i.e., atezolizumab/bevacizumab)

3. ECOG performance status 0-2

4. Patients who will have baseline biopsy for HCC and background liver biopsy per SOC

Exclusion Criteria

1. Prior systemic therapy for HCC

2. Any contraindication to immunotherapy

a) Prior transplant

b) Uncontrolled autoimmune diseases (i.e., autoimmune hepatitis)

3. Prior anti-PD-L1, anti-PD1, or anti-CTLA4 antibody (or another checkpoint inhibitor)

Study Design

Arm Groups

Study Contact


Regulatory Point of Contact
Alicia Coderoni
(210) 450-1000
coderoni@uthscsa.edu

Regulatory Point of Contact
Frances Crawford
(210) 450-5037
crawfordf1@uthscsa.edu

Regulatory Point of Contact
Sonia Creighton
(210) 450-1366
creighton@uthscsa.edu

Regulatory Point of Contact
Myrna Montenegro
(210) 450-5954
montenegro@uthscsa.edu

Regulatory Point of Contact
Mailbox Ctrc Regulatory Affairs
regaffapp@uthscsa.edu

Regulatory Point of Contact
Kathleen Rodriguez
(210) 450-1365
rodriguezk3@uthscsa.edu

Regulatory Point of Contact
Benjamin Schleif
(210) 450-1366
schleifb@uthscsa.edu

Regulatory Point of Contact
Morgan Seekatz
(210) 450-1133
seekatz@uthscsa.edu

Principal Investigator
Sukeshi Arora