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The patients will be treated with one of the standard neoadjuvant protocols (FLOT or FOLFOX.) If no decline in ctDNA detected after 4 cycles, treatment will be switched to a different chemotherapy backbone (e.g. irinotecan based regimen, or taxane based if not used upfront).

ctDNA will be re-evaluated after 3 cycles (if a 21 day regimen) or 4 cycles (if a 14 day regimen) of the 2nd line regimen. If ctDNA is lower than the previous measurement, then the same regimen continues for 3-4 more cycles (depending on 14 day or 21 day cycle), followed by gastrectomy. Adjuvant treatment is given based on the investigator's discretion.

Blood will be collected for ctDNA testing

ctDNA Blood Test

* 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

FLOT

* 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

FOLFOX

* 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

FOLFIRI

* 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

FOLFIRINOX

* 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

PACLITAXEL with or without CARBOPLATIN

* 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

DOCETAXEL and IRINOTECAN (alone or combined)

* 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

NIVOLUMAB (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

PEMBROLIZUMAB (alone or when added to a regimen above)

Chao Family Comprehensive Cancer Center University of California, Irvine

University of California Irvine Medical

Farshid Dayyani, MD, PhD

Farshid Dayyani, MD,PhD

This is a phase 1b prospective, single arm, open-label trial determining the efficacy and feasibility of using a ctDNA assay (test) result to help guide neoadjuvant chemotherapy in subjects with Stage IB, II or Stage III adenocarcinoma of the stomach or gastroesophageal junction (GEA).

Response Adapted Neoadjuvant Therapy in Gastroesophageal Cancers (RANT-GC Trial)

Response Adapted Neoadjuvant Therapy in Gastroesophageal Cancers (RANT-GC Trial) - a Phase Ib Feasibility Trial

Percent of patients who will undergo attempt at curative intent resection.

Percent of patients completing gastrectomy

Percent of patients with ctDNA clearance after neoadjuvant chemotherapy and after surgery (within 6-8 weeks)

R0 resection is defined as complete tumor removal with negative surgical margins.

Toxicity and adverse events are based on the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 5.0.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Response Adapted Neoadjuvant Therapy in Gastroesophageal Cancers (RANT-GC Trial)	NCT05733689	Gastroesophagea...	ctDNA Blood Tes... FLOT FOLFOX FOLFIRI FOLFIRINOX PACLITAXEL with... DOCETAXEL and I... NIVOLUMAB (alon... PEMBROLIZUMAB (...	18 Years -	University of California, Irvine
Response Adapted Neoadjuvant Therapy in Gastroesophageal Cancers (RANT-GC Trial)	NCT05733689	Gastroesophagea...	ctDNA Blood Tes... FLOT FOLFOX FOLFIRI FOLFIRINOX PACLITAXEL with... DOCETAXEL and I... NIVOLUMAB (alon... PEMBROLIZUMAB (...	18 Years -	University of California, Irvine

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