Study on Chemotherapy and Immunotherapy Combinations for Locally Advanced Rectal Cancer

Inclusion Criteria

• Must be 18 years or older.
• Have a good overall health status, with an ECOG performance score of 0 or 1.
• Have rectal cancer located at or below a specific area in the pelvis, confirmed by MRI or ultrasound.
• Have a specific type of rectal cancer that is stable at the genetic level (MSS or pMMR).
• Must not have received any previous chemotherapy or radiation treatment.
• Be a candidate for surgery that preserves the anal sphincter after receiving the study treatment.
• Have specific clinical staging of the cancer, such as:
  • Tumor invading certain layers of the rectum but not spreading to distant organs.
  • Presence of certain sized lymph nodes near the rectum.
• No evidence of cancer spread to distant organs on imaging tests.
• Have adequate organ and bone marrow function based on lab tests.
• Have a heart function test showing a pumping ability of 50% or higher.
• Agree to use effective birth control during the study.
• Be able to understand and sign a consent form to participate.

Exclusion Criteria

• Have used an experimental drug or device within 28 days before starting the study treatment.
• Need any other cancer treatment while on the study.
• Had major surgery within 28 days before starting the study treatment, except for minor procedures.
• Have previously been treated with certain types of immunotherapy drugs.
• Are currently using long-term steroid medications.
• Have had severe allergic reactions to similar drugs.
• Have a history of certain brain or nervous system conditions within the past year.
• Have uncontrolled infections like HIV, hepatitis B or C, or tuberculosis.
• Have other serious health conditions that are not well-controlled.
• Have an active autoimmune disease.
• Have had any organ transplant.
• Have low oxygen levels in the blood or need home oxygen.
• Have significant heart disease or high levels of certain heart markers.
• Have conditions that would prevent following the study schedule, such as substance abuse or lack of access to veins for blood draws.
• Are pregnant or breastfeeding.
• Are unwilling or unable to follow the study schedule.
• Have received a live vaccine within 30 days before starting the study treatment.
• Have received a COVID-19 vaccine within one week before starting the study treatment.
• Have certain advanced stages of cancer or specific tumor characteristics that make them ineligible.
• Have untreated bowel obstruction due to rectal cancer.