Concurrent Induction Chemoimmunotherapy With Epirubicine, Oxaliplatin, Capecitabine and Panitumumab in KRAs Wild-type, Resectable Type II Gastric Adenocarcinoma

A Two Stage Multicenter Phase II Trial of Concurrent Induction Chemoimmunotherapy With Epirubicine, Oxaliplatin, Capecitabine and Panitumumab in KRAs Wild-type, Resectable Type II Gastric Adenocarcinoma

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01351038

Enrollment

Registered

2011-05-10

Start date

Unknown

Completion date

Unknown

Last updated

2013-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

KRAS Wild Type, Resectable Type II Gastric Adenocarcinoma

Brief summary

This is an open label, multicenter, single-arm phase II trial with primary eqirubicine-oxaliplatin-capecitabine chemotherapy and concurrent Pmab in patients with resectable, histologically proven gastric or esophageal cancer.

Interventions

DRUGEpirubicine, Oxaliplatin, Capecitabine, Panitumumab

3 cycles (repeated q 21d) Epirubicine 50mg/m² i.v. d1 Oxaliplatin 100mg/m² i.v. d1 Panitumumab 9mg/kg i.v. d1 Capecitabine 500mg/m² bid d1-21

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Untreated, histologically confirmed, KRAS wild type, resectable gastric or esophageal adenocarcinoma * T2-4 NX M0 disease * ECOG performance status 0-1 * adequate hematological status * adequate renal function * adequate hepatic function * adequate metabolic function

Exclusion criteria

* pregnant or breast feeding women * previous malignancy other than gastric cancer in the last 5 years except curatively treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix * arterial or venous thromboembolism within 6 months before enrollment * clinically significant cardiovascular disease within 1 year before enrollment * history of interstitial lung disease

Design outcomes

Primary

Measure	Time frame	Description
Efficacy	—	Proportion of patients with T0 ant T1 disease after neoadjuvant combined chemoimmunotherapy
Safety	—	Proportion of patients with grade 4 diarrhea

Secondary

Measure	Time frame	Description
Progression free survival after one year	—	—
Histopathological response	—	rate of complete pathological response
Safety	—	NCI CTCAE v.3
Proportion of patients completing 3 treatment cycles	—	—
overall survival after one year	—	—

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026