Chemoimmunotherapy + Surgery for Gastric and Esophageal Cancer

(TORO Trial)

Overseen By Frances Allison

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Must not be taking: Immunosuppressive drugs

Disqualifiers: Peritoneal dissemination, Multiple brain metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 31

72 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a combination of chemoimmunotherapy (a treatment that uses drugs to enhance the immune system's ability to fight cancer) and surgery for individuals with specific types of esophageal or gastroesophageal junction cancer. The researchers aim to determine if adding surgery to the treatment plan can extend the lives of patients with cancer that has spread to only a few locations (oligometastatic disease). The treatment may also include targeted radiation. Suitable candidates for this trial are those diagnosed with esophageal or gastroesophageal cancer that has spread to a maximum of five spots, which can be treated with surgery or radiation. As an unphased trial, this study provides patients the opportunity to contribute to innovative research that could lead to new treatment strategies.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor to get specific guidance based on your situation.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that combining immunotherapy with chemotherapy, known as chemoimmunotherapy, is generally well-tolerated by patients with esophageal and gastric cancers. For instance, studies indicate that patients receiving this combined treatment had a 1-year survival rate of 95.5%. Another study found that using immune checkpoint inhibitors (ICIs) with chemotherapy improved cancer response rates and was practical for patients. Additionally, research on this treatment demonstrated significant survival benefits, with patients living up to a median of 23.7 months.

Regarding safety, other studies have successfully used chemoimmunotherapy, suggesting it is manageable for most patients. However, like any treatment, side effects can occur, so participants should discuss these with their healthcare providers. Overall, the evidence supports that this treatment approach is a promising option for those with esophageal and gastric cancers. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about chemoimmunotherapy combined with surgical resection for gastric and esophageal cancer because it offers a novel approach by integrating immune system activation with traditional cancer surgery. Unlike standard treatments, which typically involve chemotherapy or surgery alone, this method aims to shrink tumors with chemoimmunotherapy before surgery, potentially making them easier to remove and improving outcomes. By leveraging the body's immune response, it could enhance the effectiveness of surgery and provide better long-term control of the disease, especially in cases with limited metastasis.

What evidence suggests that chemoimmunotherapy and surgery might be effective for esophageal and gastric cancer?

This trial will evaluate the effectiveness of chemoimmunotherapy followed by surgical resection for patients with oligometastatic esophagogastric cancer. Research has shown that combining chemotherapy and immunotherapy (known as chemoimmunotherapy) before surgery can significantly improve outcomes for patients with esophageal and gastric cancers. One study found that this approach nearly tripled the rate of complete tumor disappearance and increased the rate of significant tumor shrinkage. Another trial demonstrated that adding immunotherapy to the usual treatment reduced the likelihood of cancer recurrence. These findings suggest that using chemoimmunotherapy before surgery is a promising strategy to extend the lives of patients with these cancers. ^{2 6 7 8 9}

Who Is on the Research Team?

Dr. Elliot Wakeam

Principal Investigator

Toronto General Hospital-UHN

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 with a specific type of esophageal or gastroesophageal junction cancer that has spread to a limited number of other areas (up to five lesions in no more than two organs). Participants must be relatively healthy, able to perform daily activities with ease or minor difficulty, and have good heart, lung, kidney, and liver function. Pregnant women cannot participate.

Inclusion Criteria

My heart and lung functions are confirmed to be adequate.

My blood tests meet the requirements for cancer treatment.

My kidney and liver functions are within the required ranges.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Chemoimmunotherapy

Participants receive pre-operative chemoimmunotherapy for oligometastatic esophagogastric cancer

8-12 weeks

Surgery

Participants undergo surgical resection following chemoimmunotherapy

1 week

1 visit (in-person)

Follow-up

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

5 years

Multiple visits at 30 days, 6 months, 1 year, 18 months, 2 years, and 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Chemoimmunotherapy
• Surgical resection

Trial Overview The study tests the effectiveness of combining pre-operative chemoimmunotherapy with surgery (and possibly targeted radiation) for patients with oligometastatic esophagogastric cancer. The goal is to see if this approach can extend patients' lives compared to current treatments.

How Is the Trial Designed?

Group I: Surgical Arm Experimental Treatment 1 Intervention

Surgical resection followed by preoperative chemoimmunotherapy for oligometastatic esophagogastric cancer

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10022879/

Immunotherapy in the Management of Esophagogastric Cancer Despite this relative improvement, the 5-year survival remained only about 50%. Attempts to improve outcomes using adjuvant chemotherapy alone, on the basis of ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.4_suppl.430

A systematic review and meta-analysis. Neoadjuvant chemoimmunotherapy significantly improved pCR rate (RR 2.94; 95% CI 2.34-3.70; P<0.00001; I2=33%), and MPR rate (RR 1.47; 95% CI ...

3. mskcc.org mskcc.org/news/new-hope-for-people-with-stomach-and-esophagus-cancer-using-immunotherapy-to-help-prevent-disease-from-coming-back

New Hope for People With Stomach and Esophagus Cancer In the Matterhorn clinical trial, the risk of cancer coming back was significantly reduced by strengthening the standard treatment with the ...

4. annalsofoncology.org annalsofoncology.org/article/S0923-7534(24)04906-8/fulltext

Adjuvant immunotherapy in patients with resected gastric ... The median survival of patients with node-positive resected cancer (ypN1-3) was only 16 months, and the 5-year survival rate was only 20%.

5. cell.com cell.com/cell-reports-medicine/pdf/S2666-3791(25)00118-1.pdf

Phase 2 trial of perioperative chemo-immunotherapy for ... identified that increased CD68+STING+ density was negatively associated with objective response to anti-PD-L1 therapy among patients with ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7061183/

Esophageal, gastric cancer and immunotherapy With the addition of durvalumab to standard tri-modality treatment, patients had 1-year relapse-free survival (RFS) of 79.2% and 1-year overall survival of 95.5 ...

7. advancesradonc.org advancesradonc.org/article/S2452-1094(25)00177-0/fulltext

Survival Benefit of Combined Chemoimmunotherapy and ... The median overall survival was 23.71 months in the ICIs + RT group and 13.00 months in the ICIs group (hazard ratio, 0.53; 95% CI, 0.31-0.88; P = .013). The ...

8. esmogastro.org esmogastro.org/article/S2949-8198(24)00033-5/fulltext

Safety and efficacy of first-line nivolumab plus chemotherapy ... At a median follow-up of 14.0 months, the median progression-free survival (PFS) and overall survival (OS) were 7.9 and 21.7 months, ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S1040842825003294

Immunotherapy in gastric adenocarcinoma – a rapidly ... Perioperative immunotherapy with chemotherapy resulted in improved event-free survival for patients with gastric cancer. •. Biomarkers such as CPS and MSI ...