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New combo therapy aims to wipe out rectal cancer before surgery

NCT ID NCT06577194

Disease control Sponsor: The First Affiliated Hospital with Nanjing Medical University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 11, 2026 · Updated 5 times

Summary

This phase 2 trial tests a new approach for people with locally advanced rectal cancer. Participants first receive a short course of radiation, followed by a combination of immunotherapy (sintilimab and IL-2) and chemotherapy (CAPOX). The goal is to see if this treatment can make the tumor completely disappear before any surgery is needed. The study will enroll 35 adults aged 18 to 70.

What this could mean

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

Active substance
Sintilimab (PD-1 antibody) plus IL-2 plus CAPOX chemotherapy
What this could lead to
If successful, this combination could increase the chance of complete tumor disappearance before surgery, potentially allowing some patients to avoid surgery altogether.
What could go wrong
This is a small, early-phase trial with only 35 people, so results may not apply broadly. The combination of treatments may cause significant side effects, and it is not yet known if it will improve long-term outcomes.

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

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

35 people

The number who actually took part.

Started

Oct 2024

Expected to finish

Jan 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age 18 to 70 years at enrollment. * Histologically confirmed rectal adenocarcinoma with the inferior tumor border within 12 cm of the anal verge. * Pelvic MRI stage T3-T4, or any T stage with regional lymph-node involvement. * Absolute neutrophil count \>=1.5 x 10\^9/L and platelet count \>=75 x 10\^9/L. * Total bilirubin \<=1.5 x the upper limit of normal; aspartate aminotransferase and alanine aminotransferase \<=2.5 x the upper limit of normal. * Serum creatinine \<=1.5 x the upper limit of normal. * Eastern Cooperative Oncology Group performance status 0 or 1. * Ability and willingness to provide written informed consent. Exclusion Criteria: * Distant metastatic disease. * Recurrent rectal cancer. * Tumor-related bleeding or perforation, or another condition requiring emergency surgery. * Previous systemic anticancer treatment for rectal cancer. * A concurrent malignancy other than colorectal cancer. * Active autoimmune disease, or a history of autoimmune disease requiring systemic corticosteroids or other immunosuppressive therapy. * Interstitial lung disease, non-infectious pneumonitis, or another uncontrolled systemic disease. * Unresolved toxicity of grade 2 or higher from previous treatment, except anemia, alopecia or pigmentation changes. * Previous treatment targeting PD-1, PD-L1 or CTLA-4. * Pregnancy or breastfeeding. * Human immunodeficiency virus infection or acquired immunodeficiency syndrome. * Known hypersensitivity to any protocol treatment component.

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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.

Advanced solid tumor Rectal cancer

Contacts and locations

Locations

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210000, China

More trials for these conditions

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