New combo therapy aims to wipe out rectal cancer before surgery

NCT ID NCT07381400

Not yet recruiting Disease control Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether adding an immunotherapy drug (serplulimab) to standard chemotherapy before surgery can improve outcomes for people with a common type of locally advanced rectal cancer (MSS/pMMR). About 128 participants will be randomly assigned to receive either chemo alone or chemo plus immunotherapy for six cycles before surgery. The main goal is to see if the combination leads to a higher rate of complete cancer disappearance (pathological complete response).

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: mFOLFOX6 chemotherapy and serplulimab (an immunotherapy drug)
What this could lead to: If successful, this combination could increase the chance of eliminating all cancer before surgery, potentially reducing the need for more aggressive treatments.
What could go wrong: This is an early phase 2 trial with only 128 participants, so results may not apply to everyone. Immunotherapy can cause immune-related side effects, and the added benefit over chemotherapy alone is uncertain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

rectal cancer rectal neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

RECTAL CANCER

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Other studies related to the condition(s) this trial covers.