Chemoimmunotherapy followed by surgery for limited spread esophageal and gastric cancer
Chemoimmunotherapy Followed by Surgery for Oligometastatic Esophageal and Gastric Cancer: A Phase II Clinical Trial (TORO Protocol)
This study is testing if a combination of chemotherapy, immunotherapy, and surgery can help people with a limited spread of esophageal or gastric cancer live longer and have fewer recurrences.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Drugs / interventions | chemotherapy, radiation, immunotherapy |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT06668454 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of pre-operative chemoimmunotherapy followed by surgical resection in patients with oligometastatic esophageal or gastric cancer. The study aims to assess the potential benefits of combining immunotherapy with surgery and possibly targeted radiation therapy to improve patient outcomes. Patients with a limited number of metastases will be treated and monitored for survival and recurrence rates. The trial seeks to provide valuable data on the safety and efficacy of this treatment approach.
Who should consider this trial
Good fit: Ideal candidates include individuals with histologically-proven oligometastatic esophageal or gastric cancer who have a maximum of five metastatic lesions and an ECOG performance status of 0 or 1.
Not a fit: Patients with widespread metastatic disease or those with a performance status worse than 1 may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly prolong the lifespan and improve the quality of life for patients with oligometastatic esophagogastric cancer.
How similar studies have performed: Previous studies have shown promising results for similar approaches, indicating potential for significant advancements in treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically-proven cT1-4aN0-3M1 adenocarcinoma or squamous cell carcinoma of the esophagus, or EGJ according to the 8th edition of the Union for International Cancer Control (UICC) TNM classification for Esophageal Cancer; * Oligometastatic disease, which is defined as a maximum of five metastatic lesions, that is treatable by surgical resection or radiation. These five lesions can be present in a maximum of two organs (eg, liver, lung or adrenal gland). Lymph nodes are not counted as an organ. If metastatic retroperitoneal or supraclavicular lymph nodes are present, this lymph node site counts as one metastatic lesion, and together with the possible metastases in organs cannot exceed the number of five lesions. * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1; * Adequate cardiac and respiratory function by standard electrocardiogram and additional diagnostics in case of cardiopulmonary complaints or comorbidity (i.e. lung function test, or echocardiography) * Adequate blood work parameters for systemic therapy as per treating medical oncologist in terms of ANC, platelet count and hemoglobin. * Adequate renal function (glomerular filtration rate \>50 mL/min or serum creatinine ≤1.5x upper level of normal (ULN)) and adequate liver function (total bilirubin \< 2.5x ULN and alanine transaminase (ALT) \< 3x ULN); * A negative serum pregnancy test in women of child-bearing potential during screening period. * Age \>18 and \<80 years old Exclusion Criteria: * Patients with overt peritoneal or pleural dissemination, as detected on PET-CT or regular CT-scan. In patients in whom a diagnostic laparoscopy is indicated (to assess gastric involvement and the possibility to perform gastric tube reconstruction or to exclude peritoneal disease), tumor-positive cytology peritoneal fluid is also an exclusion criteria. Of note, positive microscopic peritoneal cytology which converts to negative after treatment is not an exclusion criteria (i.e. peritoneal or pleural fluid cytology must be negative at the time of enrollment, with no gross disease identified initially). * Multiple bone or brain metastases - up to one solitary bone met and/one solitary brain met is allowable as a metastatic site, if curative ablative radiotherapy can be given at the discretion of the treating physicians. Patients with multiple brain metastases or multiple bone metastases will be excluded. * Any other condition that, in the opinion of the investigator, would make the patient unsuitable for the study; particularly any condition that would make the patient unfit for surgery, radiation, chemotherapy or a combination thereof. * Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs) except vitiligo or resolved childhood asthma/atopy. Replacement therapy, such as thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, is not considered a form of systemic treatment and is allowed. Use of non-systemic steroids is permitted. * Patients with active pregnancy, or lactation.
Where this trial is running
Toronto, Ontario
- Toronto General Hospital, University Health Network — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Dr. Elliot Wakeam — Toronto General Hospital-UHN
- Study coordinator: Frances Allison
- Email: Frances.Allison@uhn.ca
- Phone: 437-233-4303
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.