Gastroesophageal AdenocarcinomaPhase 1NCT05733689
Response Adapted Neoadjuvant Therapy in Gastroesophageal Cancers (RANT-GC Trial)
A Phase 1 study testing FLOT, FOLFOX and FOLFIRI in people with Gastroesophageal Adenocarcinoma, run by University of California, Irvine at 1 site in United States.
Trial summary
This is a phase 1b prospective, single arm, open-label trial determining the efficacy and feasibility of using a response-guided approach to help guide neoadjuvant chemotherapy in subjects with Stage IB, II or Stage III adenocarcinoma of the stomach or gastroesophageal junction (GEA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroesophageal Adenocarcinoma
- What is being tested?
- FLOT, FOLFOX and FOLFIRI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jun 2025to Jun 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (GEA). Other GE histologies which are treated per NCCN guidelines for neoadjuvant treatment are eligible.
- Must have Stage IB, II or Stage III GEA eligible for (neo)adjuvant doublet or triplet chemotherapy for up to 6 months.
- Age ≥ 18 years Because the safety or efficacy of neoadjuvant chemotherapy for LGEA has not been tested or established for patients <18 years of age, children are excluded from this study but will be eligible for future pediatric trials, if applicable.
- Performance status: ECOG performance status ≤2
- Life expectancy of greater than 6 months
- Adequate organ and marrow function as defined below:
Show all 17Show fewer
- hemoglobin ≥ 7g/dL
- absolute neutrophil count ≥ 1,500/mcL
- platelets ≥ 80,000/mcl
- total bilirubin within normal institutional limits
- AST(SGOT)/ALT(SPGT) ≤ 5 X institutional upper limit of normal
- creatinine <2 X ULN
- Docetaxel can cause fetal harm and irinotecan is known to be teratogenic. Since these compounds are part of the treatment regimens, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- 1. A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
- Ability to understand and the willingness to sign a written informed consent. 1. Both men and women and members of all races and ethnic groups are eligible for this trial. Non-English speaking, deaf, hard of hearing and illiterate individuals are eligible for this trial.
Who cannot join
- Patients may not be receiving any other investigational agents.
- Patients with known distant metastases from GEA.
- History of allergic reactions attributed to agents used in study.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- History of another primary cancer which requires active treatment or is expected to require treatment within 12 months after enrollment.
- Inability to comply with study and follow-up procedures as judged by the Investigator.
- Patients who are pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
- Patients with prior organ/bone marrow/non-autologous stem cell transplants
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chao Family Comprehensive Cancer Center University of California, Irvine contact
University of California Irvine Medical contact
United States1 site, 1 recruiting
- Recruiting
Chao Family Comprehensive Cancer Center, University
Orange, California, 92868
Farshid Dayyani, MD, PhD, 877-827-8839, ucstudy@uci.edu
About this study
Official title: Response Adapted Neoadjuvant Therapy in Gastroesophageal Cancers (RANT-GC Trial) - a Phase Ib Feasibility Trial
This is a phase 1b prospective, single arm, open-label trial determining the efficacy and feasibility of using a response-guided approach to help guide neoadjuvant chemotherapy in subjects with Stage IB, II or Stage III adenocarcinoma of the stomach or gastroesophageal junction (GEA).
- Conditions
- Gastroesophageal Adenocarcinoma
- Being tested
- FLOT, FOLFOX, FOLFIRI, FOLFIRINOX, PACLITAXEL with or without CARBOPLATIN
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLOTCombination product
- Oxaliplatin 85 mg/m2 IV on Day 1
- Docetaxel 50 mg/m2 IV on Day 1
- Leucovorin 200 mg/m2 IV on Day 1
- Fluorouracil 2600 mg/m2 continuous infusion over 24 hours daily on Day 1 Every 14 Days
FOLFOXCombination product
- Oxaliplatin 85 mg/m2 IV on Day 1
- Leucovorin 400 mg/m2 IV on Day 1
- Fluorouracil 400 mg/m2 IV Push on Day 1
- Fluorouracil 1200 mg/m2 continuous infusion over 24 hours daily on Days 1 and 2 Every 14 Days
FOLFIRICombination product
- Irinotecan 180 mg/m2 IV on Day 1
- Leucovorin 400 mg/m2 IV on Day 1
- Fluorouracil 400 mg/m2 IV Push on Day 1
- Fluorouracil 1200 mg/m2 continuous infusion over 24 hours daily on Days 1 and 2 Every 14 Days
FOLFIRINOXCombination product
- Oxaliplatin 85 mg/m2 IV on Day 1
- Irinotecan 150 mg/m2 IV on Day 1
- Leucovorin 200 mg/m2 IV on Day 1
- Fluorouracil 1200 mg/m2 continuous infusion over 24 hours daily on Days 1 and 2 Every 14 days
PACLITAXEL with or without CARBOPLATINCombination product
- Paclitaxel 200 mg/m2 IV on Day 1
- Carboplatin AUC 5 IV on day 1 Every 21 Days
OR
- Paclitaxel 80mg/m2 IV on Days 1,8,15 Every 28 Days
DOCETAXEL and IRINOTECAN (alone or combined)Combination product
- Docetaxel 35 mg/m2 IV on Days 1 and 8
- Irinotecan 50 mg/m2 IV on Days 1 and 8 Every 21 Days
- Docetaxel 75 mg/m2 IV on Day 1 Every 21 Days
- Docetaxel 150 mg/m2 IV on Day 1 Every 14 Days
NIVOLUMAB (alone or when added to a regimen above)Drug
- 240 mg IV on Day 1 every 14 days, or
- 360 mg IV on Day 1 every 21 days, or
- 480 mg IV on Day 1 every 28 days
PEMBROLIZUMAB (alone or when added to a regimen above)Drug
- 200 mg IV on Day 1 every 21 days, or
- 400 mg IV on Day 1 every 42 days
DurvalumabDrug
- 1500 mg IV on Day 1 every 28 days
TrastuzumabDrug
- 8 mg/kg on Day 1, then 6 mg/kg IV every 21 days, or
- 6 mg/kg on Day 1, then 4 mg/kg IV every 14 days
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant chemotherapy with ctDNA testing | Experimental | The patients will be treated with one of the standard neoadjuvant protocols (FLOT or FOLFOX.) If patient response to their treatment, as measured by CT Scans or MRI results or blood tests done to look tumor markers such as carcinoembryonic antigen (CEA) and Carbohydrate antigen 19-9 (CA19-9) a change in adjuvant treatment will be made. Receives: Combination Product: FLOT; Combination Product: FOLFOX; Combination Product: FOLFIRI; Combination Product: FOLFIRINOX; Combination Product: PACLITAXEL with or without CARBOPLATIN; Combination Product: DOCETAXEL and IRINOTECAN (alone or combined); Drug: NIVOLUMAB (alone or when added to a regimen above); Drug: PEMBROLIZUMAB (alone or when added to a regimen above); Drug: Durvalumab; Drug: Trastuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of completing per protocol treatment.
Percent of patients who will undergo attempt at curative intent resection.
Measured: Up to 3 years
Secondary outcomes (5)
Percentage of patients completing gastrectomy.
Percent of patients completing gastrectomy
Measured: Up to 3 years
Rate of negative ctDNA after completion of neoadjuvant treatment and within 8 weeks after surgery
Percent of patients with ctDNA clearance after neoadjuvant chemotherapy and after surgery (within 6-8 weeks)
Measured: 8 weeks
Rate of R0 resection
R0 resection is defined as complete tumor removal with negative surgical margins.
Measured: Up to 3 years
Percentage of Grade 3-5 Adverse Events
Toxicity and adverse events are based on the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 5.0.
Measured: Up to 3 years
Relapse-free survival time
The lead time in ctDNA detection before clinical recurrence
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start27 Jun 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- BillionToOne Inc.
- Responsible party
- Principal investigator, Farshid Dayyani, University of California, Irvine
- Investigators
- Farshid Dayyani, MD,PhD, Principal investigator, Chao Family Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05733689
- Sponsor's protocol ID
- 1977
- Other IDs
- UCI 21-191
- Status last verified
- Mar 2026
- First submitted
- 8 Feb 2023
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response Adapted Neoadjuvant Therapy in Gastroesophageal Cancers (RANT-GC Trial) - a Phase Ib Feasibility Trial
- ClinicalTrials.gov ID
- NCT05733689
- Acronym / sponsor ID
- 1977
- Conditions
- Gastroesophageal Adenocarcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- BillionToOne Inc.
- Study start
- 27 Jun 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 17 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 1b prospective, single arm, open-label trial determining the efficacy and feasibility of using a response-guided approach to help guide neoadjuvant chemotherapy in subjects with Stage IB, II or Stage III adenocarcinoma of the stomach or gastroesophageal junction (GEA).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant chemotherapy with ctDNA testing | Experimental | Combination Product: FLOT, Combination Product: FOLFOX, Combination Product: FOLFIRI, Combination Product: FOLFIRINOX, Combination Product: PACLITAXEL with or without CARBOPLATIN, Combination Product: DOCETAXEL and IRINOTECAN (alone or combined), Drug: NIVOLUMAB (alone or when added to a regimen above), Drug: PEMBROLIZUMAB (alone or when added to a regimen above), Drug: Durvalumab, Drug: TrastuzumabThe patients will be treated with one of the standard neoadjuvant protocols (FLOT or FOLFOX.) If patient response to their treatment, as measured by CT Scans or MRI results or blood tests done to look tumor markers such as carcinoembryonic antigen (CEA) and Carbohydrate antigen 19-9 (CA19-9) a change in adjuvant treatment will be made. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patients must have histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (GEA). Other GE histologies which are treated per NCCN guidelines for neoadjuvant treatment are eligible.
- Must have Stage IB, II or Stage III GEA eligible for (neo)adjuvant doublet or triplet chemotherapy for up to 6 months.
- Age ≥ 18 years Because the safety or efficacy of neoadjuvant chemotherapy for LGEA has not been tested or established for patients <18 years of age, children are excluded from this study but will be eligible for future pediatric trials, if applicable.
- Performance status: ECOG performance status ≤2
- Life expectancy of greater than 6 months
Key exclusion criteria (8 listed)
- Patients may not be receiving any other investigational agents.
- Patients with known distant metastases from GEA.
- History of allergic reactions attributed to agents used in study.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- History of another primary cancer which requires active treatment or is expected to require treatment within 12 months after enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FLOT* Oxaliplatin 85 mg/m2 IV on Day 1 * Docetaxel 50 mg/m2 IV on Day 1 * Leucovorin 200 mg/m2 IV on Day 1 * Fluorouracil 2600 mg/m2 continuous infusion over 24 hours daily on Day 1 Every 14 Days | Combination product | Neoadjuvant chemotherapy with ctDNA testing |
| FOLFOX* Oxaliplatin 85 mg/m2 IV on Day 1 * Leucovorin 400 mg/m2 IV on Day 1 * Fluorouracil 400 mg/m2 IV Push on Day 1 * Fluorouracil 1200 mg/m2 continuous infusion over 24 hours daily on Days 1 and 2 Every 14 Days | Combination product | Neoadjuvant chemotherapy with ctDNA testing |
| FOLFIRI* Irinotecan 180 mg/m2 IV on Day 1 * Leucovorin 400 mg/m2 IV on Day 1 * Fluorouracil 400 mg/m2 IV Push on Day 1 * Fluorouracil 1200 mg/m2 continuous infusion over 24 hours daily on Days 1 and 2 Every 14 Days | Combination product | Neoadjuvant chemotherapy with ctDNA testing |
| FOLFIRINOX* Oxaliplatin 85 mg/m2 IV on Day 1 * Irinotecan 150 mg/m2 IV on Day 1 * Leucovorin 200 mg/m2 IV on Day 1 * Fluorouracil 1200 mg/m2 continuous infusion over 24 hours daily on Days 1 and 2 Every 14 days | Combination product | Neoadjuvant chemotherapy with ctDNA testing |
| PACLITAXEL with or without CARBOPLATIN* Paclitaxel 200 mg/m2 IV on Day 1 * Carboplatin AUC 5 IV on day 1 Every 21 Days OR - Paclitaxel 80mg/m2 IV on Days 1,8,15 Every 28 Days | Combination product | Neoadjuvant chemotherapy with ctDNA testing |
| DOCETAXEL and IRINOTECAN (alone or combined)* Docetaxel 35 mg/m2 IV on Days 1 and 8 * Irinotecan 50 mg/m2 IV on Days 1 and 8 Every 21 Days * Docetaxel 75 mg/m2 IV on Day 1 Every 21 Days * Docetaxel 150 mg/m2 IV on Day 1 Every 14 Days | Combination product | Neoadjuvant chemotherapy with ctDNA testing |
| NIVOLUMAB (alone or when added to a regimen above)* 240 mg IV on Day 1 every 14 days, or * 360 mg IV on Day 1 every 21 days, or * 480 mg IV on Day 1 every 28 days | Drug | Neoadjuvant chemotherapy with ctDNA testing |
| PEMBROLIZUMAB (alone or when added to a regimen above)* 200 mg IV on Day 1 every 21 days, or * 400 mg IV on Day 1 every 42 days | Drug | Neoadjuvant chemotherapy with ctDNA testing |
| Durvalumab- 1500 mg IV on Day 1 every 28 days | Drug | Neoadjuvant chemotherapy with ctDNA testing |
| Trastuzumab* 8 mg/kg on Day 1, then 6 mg/kg IV every 21 days, or * 6 mg/kg on Day 1, then 4 mg/kg IV every 14 days | Drug | Neoadjuvant chemotherapy with ctDNA testing |
Primary outcome
Percentage of completing per protocol treatment.
Time frame: Up to 3 years
Percent of patients who will undergo attempt at curative intent resection.
5 secondary outcomes
Percentage of patients completing gastrectomy.
Time frame: Up to 3 years
Rate of negative ctDNA after completion of neoadjuvant treatment and within 8 weeks after surgery
Time frame: 8 weeks
Rate of R0 resection
Time frame: Up to 3 years
Percentage of Grade 3-5 Adverse Events
Time frame: Up to 3 years
Relapse-free survival time
Time frame: Up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chao Family Comprehensive Cancer Center University of California, Irvine contact
University of California Irvine Medical contact
Farshid Dayyani, MD,PhD principal investigator
Chao Family Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FLOT, FOLFOX and FOLFIRI in people with Gastroesophageal Adenocarcinoma, run by University of California, Irvine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chao Family Comprehensive Cancer Center University of California, Irvine (1-877-827-8839, ucstudy@uci.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of completing per protocol treatment. (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.