New cocktail aims to shrink rectal tumors and save the sphincter

NCT ID NCT07277842

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tests whether adding an immunotherapy drug (serplulimab) to a strong chemotherapy mix (FOLFOXIRI) and radiation works better than standard chemo (CAPOX) plus radiation for people with locally advanced low rectal cancer that is microsatellite stable (pMMR). About 382 adults will be randomly assigned to one of the two treatment groups. The goal is to see if the new combo improves 3-year survival without cancer recurrence and increases the chance of a complete response, possibly allowing patients to avoid surgery or a permanent colostomy.

What this could mean

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

Active substance

serplulimab (PD-1 antibody) plus FOLFOXIRI chemotherapy (5-fluorouracil, leucovorin, oxaliplatin, irinotecan)

What this could lead to

If it works, this could improve event-free survival and increase the chance of avoiding a permanent colostomy for people with a common type of rectal cancer.

What could go wrong

This is an early-stage Phase 3 trial that hasn't started recruiting yet. The experimental combination may cause more side effects, and it's not yet known if it will be better than the standard approach.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Conditions

The condition(s) this trial relates to.

rectal cancer rectum adenocarcinoma

As listed by the trial registrant

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

Contacts and locations

Study contacts

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

Locations

  • Sun Yat-Sen University Cancer Center

    Guangzhou, None Selected, 510060, China

    Contact Phone: •••-•••-•••• Email: •••••@•••••