Actively Recruiting
Response Adapted Neoadjuvant Therapy in Gastroesophageal Cancers (RANT-GC Trial) - a Phase Ib Feasibility Trial
Led by University of California, Irvine · Updated on 2026-03-10
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of California, Irvine
Lead Sponsor
B
BillionToOne Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a response-guided approach to neoadjuvant chemotherapy in patients with Stage IB, II, or III adenocarcinoma of the stomach or gastroesophageal junction. This phase 1b, prospective, single arm, open-label trial aims to determine the effectiveness and feasibility of adjusting chemotherapy based on patient response. The trial focuses on patients eligible for standard neoadjuvant treatment protocols and seeks to improve treatment outcomes by tailoring therapy according to tumor marker changes and imaging results. Participants will receive one of several standard neoadjuvant chemotherapy regimens, including FLOT or FOLFOX, with the possibility of switching treatments based on their response. Response assessments involve CT scans, MRI, and blood tests measuring tumor markers like carcinoembryonic antigen (CEA) and carbohydrate antigen 19-9 (CA19-9). Treatment adjustments may include different chemotherapy combinations such as FOLFIRI, FOLFIRINOX, or immunotherapy agents like nivolumab, pembrolizumab, durvalumab, or trastuzumab, given according to specific schedules. During the study, participants will undergo regular monitoring including imaging scans and blood tests to evaluate tumor response and treatment effects. Researchers will track completion of treatment protocols, rates of surgery (gastrectomy) completion, negative circulating tumor DNA after neoadjuvant therapy, and adverse events. The study will also assess relapse-free survival over up to three years. Participants are monitored closely for safety and adherence, with study involvement lasting up to three years to capture long-term outcomes.
CONDITIONS
Brief Title
Response Adapted Neoadjuvant Therapy in Gastroesophageal Cancers (RANT-GC Trial)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (GEA)
- Stage IB, II, or III GEA eligible for neoadjuvant doublet or triplet chemotherapy up to 6 months
- ECOG performance status of 0, 1, or 2
- Life expectancy greater than 6 months
- Adequate organ and marrow function including hemoglobin ≥7g/dL, absolute neutrophil count ≥1,500/mcL, platelets ≥80,000/mcL, normal total bilirubin, AST/ALT ≤5 times institutional upper limit, creatinine less than 2 times upper limit
- Agreement to use adequate contraception if of child-bearing potential or male
- Ability to understand and willingness to sign informed consent
- Both men and women of all races and ethnic groups eligible, including non-English speaking and those with hearing or literacy limitations
You will not qualify if you...
- Receiving other investigational agents
- Known distant metastases from gastroesophageal adenocarcinoma
- History of allergic reactions to study agents
- Uncontrolled illness such as active infection, heart failure, unstable angina, arrhythmia, or psychiatric/social issues limiting compliance
- History of another primary cancer requiring active treatment within 12 months
- Inability to comply with study procedures
- Pregnant or nursing women
- Prior organ, bone marrow, or non-autologous stem cell transplants
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months
Participants receive neoadjuvant chemotherapy using one of several standard protocols such as FLOT or FOLFOX. Treatment may be adapted based on response measured by imaging and blood tests.
Visits every 14 to 28 days depending on chemotherapy regimen
Duration - Up to 3 years
Participants are monitored after completing neoadjuvant treatment and surgery for up to 3 years to assess outcomes such as relapse-free survival and adverse events.
Follow-up visits scheduled periodically over 3 years
Trial Site Locations
Total: 1 location
1
Chao Family Comprehensive Cancer Center, University
Orange, California, United States, 92868
Actively Recruiting
Research Team
C
Chao Family Comprehensive Cancer Center University of California, Irvine
U
University of California Irvine Medical
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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