Immunotherapy plus chemotherapy shows promise in rectal cancer trial

NCT ID NCT07528209

First seen Jun 27, 2026 ยท Last updated Jun 27, 2026

Summary

This phase 3 trial is testing whether adding the immunotherapy drug pucotenlimab to standard chemotherapy (CAPOX) before surgery can improve outcomes for people with locally advanced rectal cancer. About 556 participants will be randomly assigned to receive either CAPOX plus pucotenlimab or CAPOX alone, with some also receiving radiotherapy based on tumor response. The main goal is to see if the combination improves 3-year disease-free survival.

What this could mean

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

Active substance
Pucotenlimab (an immunotherapy drug) combined with chemotherapy (CAPOX: oxaliplatin and capecitabine) and selective radiotherapy
What this could lead to
If successful, this combination could improve disease-free survival and increase the chance of a complete response before surgery for patients with locally advanced rectal cancer.
What could go wrong
This is an early-phase trial with 556 participants, so results may not apply to all patients. Immunotherapy can cause immune-related side effects, and the added benefit over standard chemotherapy alone is not yet proven.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Sun Yat-sen University Cancer Center

    RECRUITING

    Guangzhou, Guangdong, 510060, China

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