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

Trial Summary

What is the purpose of this trial?

Esophageal cancer and cancers of the gastroesophageal junction (GEJ) are among the most common malignancies worldwide. The outcome for these patients remains very poor. Patients with limited spread of their cancer (oligometastatic disease) have a better prognosis than those with widespread disease. Recent advances in treatment therapies, including use of pre-operative immunotherapy, surgery and/or targeted radiation (SBRT) may help to prolong lifespan in patients with oligometastatic disease. Patients will undergo treatment for their oligometastatic esophageal or gastric cancer with pre-operative chemoimmunotherapy followed by surgery and possibly SBRT to evaluate the value of adding surgery and possibly SBRT to their treatment.

Research Team

Dr. Elliot Wakeam

Principal Investigator

Toronto General Hospital-UHN

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+