New cocktail of chemo and antibodies shows promise against aggressive stomach cancer
NCT ID NCT01191697
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tested a combination of two chemotherapy drugs (capecitabine and oxaliplatin) plus two targeted antibodies (bevacizumab and trastuzumab) in 37 people with HER2-positive stomach or esophageal cancer that had spread. The goal was to see how safe and effective the combo was at shrinking tumors. Results showed that many patients had their tumors shrink, and the treatment helped control the disease for a time.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- capecitabine, oxaliplatin, bevacizumab (Avastin), trastuzumab (Herceptin)
- What this could lead to
- If successful, this combination could offer a new treatment option that shrinks tumors and extends life for people with HER2-positive stomach or esophageal cancer that has spread.
- What could go wrong
- This is a small, early-phase trial with only 37 participants, so results may not apply to everyone. Combining multiple drugs also raises the risk of side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
37 people
The number who actually took part.
- Started
-
Feb 2011
- Finished
-
Aug 2024
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Confirmed HER2-positive esophageal, GE junction or gastric adenocarcinoma that is metastatic or unresectable. * All patients must have available tumor sample (either paraffin block or 15 freshly cut, unstained slides) prior to study entry. Part II: Patient must have primary esophagogastric tumor in place or other tumor that is accessible for mandatory biopsy. * Measurable disease, defined in RECIST 1.1 * 18 years of age or older * Life expectancy of greater than 12 weeks * ECOG performance status of 0 or 1 * Organ and marrow function as outlined in the protocol * Women of child-bearing potential and men must agree to use adequate contraception during study participation and for 30 days from the date of the last study drug administration. * Part II only: Participant agrees to undergo mandatory pre and post loading dose of trastuzumab biopsy for correlative science. Exclusion Criteria: * Prior therapy with any of the following; capecitabine, oxaliplatin, bevacizumab or trastuzumab is not allowed. May have received and completed adjuvant therapy at least 6 months prior to study entry or one prior therapy for metastatic disease as long as it did not include any of the above agents. * Chemotherapy or radiotherapy to greater then 25% of bone marrow within 4 weeks prior to entering the study. * Palliative radiation therapy to isolated bone metastasis within 2 weeks of initiating therapy. * Major surgery, open biopsy, significant traumatic injury within 4 weeks prior to study entry,. * Minor surgery, including placement of vascular access device within 7 days prior to the first dose of bevacizumab. * Residual toxicity from prior chemotherapy and/or radiation therapy of Grade 2 or greater. * Participants may not be receiving any concurrent investigational agents * Active brain or other CNS metastasis by history or clinical examination. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to capecitabine, bevacizumab or trastuzumab. No known allergy or hypersensitivity to Chinese hamster ovary, or any of the study agents. No known DPD deficiency. * Warfarin is prohibited; anticoagulation using low molecular weight heparin is allowed. * Uncontrolled, intercurrent illness * Patients with a history of other malignancy are not eligible except for the following circumstances: disease-free for at least 3 years and are deemed to be at low risk for recurrence of that malignancy; cervical cancer in situ, basal cell or squamous cell carcinoma of the skin that was treated with curative intent within the past 5 years. * Known HIV seropositivity, hepatitis C, acute or chronic hepatitis B or other serious active infection * LVEF less than 50% as determined by MUGA scan or echocardiogram within 28 days prior to initiation of therapy * Inadequately controlled hypertension * History of prior hypertensive crisis or hypertensive encephalopathy * History of any arterial thrombosis, CVA, TIA, MI or unstable angina in past 6 months. * Evidence of bleeding diathesis or coagulopathy * Serious, unhealed wounds, bone fractures or skin ulcers * Pregnant or breast feeding * Greater than grade 1 peripheral neuropathy at baseline * Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Esophageal cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
-
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a personalized menu keep cancer patients stronger through chemotherapy?
- Blood proteins may predict who beats esophageal cancer with chemoradiation
- Nerve-Block procedure tested against severe pancreatic and stomach cancer pain
- New Antibody-Drug conjugate put to the test against Hard-to-Treat cancers
- Robotic surgery vs standard approaches: does the platform change cancer outcomes?
- Can a direct hit to tumors make immunotherapy work better?