240 Participants Needed

Novel Treatments for Stomach Cancer

Recruiting at 29 trial locations
AC
Overseen ByAstraZeneca Clinical Study Information Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing new combinations of drugs to treat advanced stomach cancer that can't be removed by surgery or has spread. Researchers want to see if these drug combinations are effective and safe, and how the body handles them. A group of patients will participate to find the best dose.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is the XELOX treatment generally safe for humans?

The XELOX treatment, which combines capecitabine and oxaliplatin, has been studied for safety in patients with advanced gastric cancer. These studies suggest that XELOX is generally safe, but like all treatments, it can have side effects, which should be discussed with a healthcare provider.12345

What makes the drug AZD2936, FOLFOX, MEDI5752, XELOX unique for stomach cancer treatment?

This treatment is unique because it combines traditional chemotherapy (FOLFOX and XELOX) with MEDI5752, a novel bispecific antibody that targets two immune checkpoints, PD-1 and CTLA4, potentially enhancing the immune system's ability to fight cancer. This combination aims to improve outcomes by leveraging both chemotherapy and advanced immunotherapy.45678

What data supports the effectiveness of the drug AZD2936, FOLFOX, FOLFOX4, FOLFOX6, FOLFOX7, MEDI5752, Volrustomig, MEDI-5752, PD-1/CTLA-4 bispecific mAb, PD-l/CTLA-4 DuetMab, XELOX, Capecitabine/Oxaliplatin for stomach cancer?

Research shows that combinations like FOLFOX and XELOX, which include drugs like oxaliplatin and capecitabine, are effective in treating advanced gastric (stomach) cancer. Additionally, MEDI5752, which targets immune checkpoints, has shown promising results in various tumors, suggesting potential benefits for stomach cancer as well.457910

Are You a Good Fit for This Trial?

Adults over 18 with a body weight above 35 kg, diagnosed with advanced gastric or gastroesophageal junction adenocarcinoma that can't be surgically removed or has spread, and who haven't been treated for it yet. Participants should have a life expectancy of at least 12 weeks and good performance status (able to carry out daily activities). Those with active infections, previous immune-oncology treatments, certain HER2-positive cancers, uncontrolled brain metastases, serious illnesses, another cancer history or uncontrollable ascites are excluded.

Inclusion Criteria

Has measurable target disease assessed by the Investigator based on RECIST 1.1
Life expectancy of at least 12 weeks
My organs and bone marrow are working well.
See 4 more

Exclusion Criteria

My stomach cancer is HER2 positive or uncertain but not negative.
I have been treated with immunotherapy before.
I do not have any uncontrolled illnesses.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive novel combination therapies, including Rilvegostomig, AZD0901, volrustomig, XELOX, FOLFOX, and AZD7789, depending on the substudy

Average of 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment, including progression-free survival and overall survival

Average of 2 years

What Are the Treatments Tested in This Trial?

Interventions

  • AZD2936
  • FOLFOX
  • MEDI5752
  • XELOX
Trial Overview The trial is testing new combinations of drugs including chemotherapy agents like 5-Fluorouracil and Capecitabine as well as novel therapies AZD0901, Rilvegostomig, FOLFOX regimen components and Volrustomig. It aims to evaluate how effective these combinations are in treating the cancer while also monitoring safety profiles and how the body processes the drugs.
How Is the Trial Designed?
6Treatment groups
Experimental Treatment
Group I: Substudy 6Experimental Treatment4 Interventions
AZD0901 plus AZD7789 and 5-fluorouracil or capecitabine
Group II: Substudy 5Experimental Treatment3 Interventions
AZD7789 plus XELOX (oxaliplatin and capecitabine) or FOLFOX (oxaliplatin and 5-FU/CF)
Group III: Substudy 4Experimental Treatment4 Interventions
AZD0901 plus rilvegostomig and 5-fluorouracil or capecitabine
Group IV: Substudy 3Experimental Treatment4 Interventions
AZD0901 plus volrustomig and 5-fluorouracil or capecitabine
Group V: Substudy 2Experimental Treatment3 Interventions
Rilvegostomig plus XELOX (oxaliplatin and capecitabine) or FOLFOX (oxaliplatin and 5-FU/CF)
Group VI: Substudy 1Experimental Treatment3 Interventions
Volrustomig plus XELOX (oxaliplatin and capecitabine) or FOLFOX (oxaliplatin and 5-FU/CF)

Find a Clinic Near You

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials
4,491
Recruited
290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from ร‰cole nationale vรฉtรฉrinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from ร‰cole nationale vรฉtรฉrinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Published Research Related to This Trial

In a phase II trial involving 63 patients with advanced gastric cancer, the combination of oxaliplatin, irinotecan, and fluorouracil/folinic acid showed a response rate of 33%, indicating it is an effective treatment option for this condition.
The treatment was generally well-tolerated, with manageable side effects; however, significant toxicities included neutropenia in 59% of patients and neurotoxicity in 33%, highlighting the need for monitoring during therapy.
Oxaliplatin, irinotecan, and fluorouracil/folinic acid in advanced gastric cancer: a multicenter phase II trial of the Southern Italy Cooperative Oncology Group.Comella, P., Lorusso, V., Maiorino, L., et al.[2018]
In a study of 51 patients with advanced or recurrent gastric cancer, the FOLFOX-6 chemotherapy regimen resulted in a 41.2% overall response rate, with 3 complete responses and 18 partial responses, indicating good efficacy.
The treatment had an acceptable safety profile, with significant toxicities including grade 3/4 neutropenia in 9.8% and anemia in 7.8% of patients, but no treatment-related deaths were reported.
A pilot study of oxaliplatin, fluorouracil and folinic acid (FOLFOX-6) as first-line chemotherapy in advanced or recurrent gastric cancer.Luo, HY., Xu, RH., Zhang, L., et al.[2022]
The study compared the efficacy and safety of two chemotherapy regimens, XELOX and FOLFOXs, in 1585 patients with advanced gastric cancer, but found no significant difference in overall response rate or clinical benefit rate between the two treatments.
XELOX was associated with lower risks of nausea, stomatitis, diarrhea, and alopecia compared to FOLFOXs, but had a higher risk of hand-foot syndrome, suggesting it may be a safer option despite similar efficacy.
Capecitabine plus oxaliplatin (XELOX) compared with 5-fluorouracil/leucovorin plus oxaliplatin (FOLFOXs) in advanced gastric cancer: meta-analysis of randomized controlled trials.Xu, HB., Huang, F., Su, R., et al.[2022]

Citations

Oxaliplatin, irinotecan, and fluorouracil/folinic acid in advanced gastric cancer: a multicenter phase II trial of the Southern Italy Cooperative Oncology Group. [2018]
A pilot study of oxaliplatin, fluorouracil and folinic acid (FOLFOX-6) as first-line chemotherapy in advanced or recurrent gastric cancer. [2022]
Capecitabine plus oxaliplatin (XELOX) compared with 5-fluorouracil/leucovorin plus oxaliplatin (FOLFOXs) in advanced gastric cancer: meta-analysis of randomized controlled trials. [2022]
MEDI5752 Suppresses Two Immune Checkpoints. [2022]
[Preliminary study of XELOX regimen as the first-line chemotherapy in advanced or recurrent gastric cancer]. [2020]
Phase I study of sunitinib plus capecitabine/cisplatin or capecitabine/oxaliplatin in advanced gastric cancer. [2022]
A prospective phase II study of cetuximab in combination with XELOX (capecitabine and oxaliplatin) in patients with metastatic and/or recurrent advanced gastric cancer. [2021]
Panitumumab combined with irinotecan for patients with KRAS wild-type metastatic colorectal cancer refractory to standard chemotherapy: a GERCOR efficacy, tolerance, and translational molecular study. [2023]
Clinical complete response after nivolumab administered as a third-line treatment for unresectable advanced gastric cancer with peritoneal dissemination: A case report. [2021]
Immune Checkpoint Inhibition in Gastro-Oesophageal Cancer. [2019]
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