Recruiting

Testing radiation and chemotherapy plus immunotherapy with or without a new drug for advanced rectal cancer

Plain-English translation of NCT07505472 on ClinicalTrials.gov ↗ · Source last updated April 2026 · Translation generated July 2026 · How we translate trials

Phase 3 — Testing in thousands of people, comparing the treatment against what doctors currently use. This is the last big step before approval.

What is this trial?

This trial is testing a combination of treatments for advanced rectal cancer that has risk factors making it harder to treat. You would receive short-course radiation therapy followed by chemotherapy combined with an immunotherapy drug called toripalimab. Half of participants will also receive surufatinib, a new medication that may boost how well the immune system fights the cancer.

Current treatment combinations for advanced rectal cancer sometimes don't work well enough, and cancer can come back or spread. This trial aims to see if adding surufatinib to the standard immunotherapy approach helps more patients achieve a complete response and better long-term outcomes.

Do you qualify?

You likely qualify if…

you have been diagnosed with advanced rectal cancer located in the middle or lower part of the rectum with high-risk features (such as larger tumor size, more lymph node involvement, or other concerning findings on imaging)
you are between 18 and 75 years old
you have not received any prior chemotherapy, radiation, or surgery for rectal cancer
you do not have cancer that has spread to distant parts of your body
your heart, lung, liver, and kidney function are healthy enough to tolerate the planned treatments

You likely don't qualify if…

you have recurrent rectal cancer (cancer that has returned after previous treatment)
you have had a heart attack, stroke, or unstable heart rhythm within the past 6 months
you have an active autoimmune disease or have had an organ or bone marrow transplant
you have untreated or active tuberculosis or a history of significant lung disease
you are pregnant, breastfeeding, or unable to use reliable contraception during and for 4 months after the study

What participation looks like

You would first receive short-course radiation therapy to the rectal area. After a brief rest, you would receive four cycles of chemotherapy combined with immunotherapy, with half of participants also taking surufatinib as a daily oral medication throughout the chemotherapy period. The entire treatment phase takes several weeks, followed by surgery to remove the cancer. You would have regular clinic visits, imaging scans, and blood tests to monitor your response and watch for side effects.

AI-generated summary from trial data · Jul 21, 2026 · Not medical advice

Trial locations(1 site)

China

the first hospital of Jilin University, Changchun, Jilin

View full record on ClinicalTrials.gov