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Immunotherapy cocktail shows promise against tough rectal cancers

NCT ID NCT06884670

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Updated 1 time

Summary

This study tested whether giving a mix of immunotherapy drugs (tislelizumab and IL-2) plus chemotherapy before surgery could shrink tumors more effectively in people with locally advanced rectal cancer. The trial involved 130 adults whose cancers had not spread but were hard to treat. The goal was to see if more patients could achieve a complete response, meaning no cancer remains at the time of surgery.

What this could mean

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

Active substance
Tislelizumab (PD-1 inhibitor), Interleukin-2, Capecitabine, Oxaliplatin
What this could lead to
If successful, this combination could become a new standard neoadjuvant treatment, increasing the chance of complete tumor disappearance before surgery for rectal cancer patients.
What could go wrong
This is a phase 2 trial with only 130 participants, so results may not apply to all patients. The combination may cause more side effects than standard therapy, and the long-term benefits are not yet proven.

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

130 people

The number who actually took part.

Started

Aug 2024

Finished

Jun 2026

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 75 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: 1. Males and females aged between 18 and 75 years; 2. An Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; 3. Histologically confirmed rectal adenocarcinoma; 4. Clinical stage T3-T4 or any T with node-positive (N+) disease: locally advanced; 5. Microsatellite stable (MSS) status; 6. Adequate hematological, hepatic, and renal functions. Exclusion Criteria: 1. Patients with metastatic disease (Stage IV); recurrent colorectal cancer with active bleeding, perforation, or complex conditions requiring urgent surgery; or concurrent non-colorectal cancer malignancies. 2. Patients who have previously received systemic anticancer therapy for colorectal cancer; or have been treated with PD-1, PD-L1, or CTLA-4 antibodies. 3. Patients with any active autoimmune disease; known or tested positive for Human Immunodeficiency Virus (HIV) or Acquired Immunodeficiency Syndrome (AIDS); or a history requiring steroid or immunosuppressive drug treatment. 4. Patients with interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic diseases (such as diabetes, hypertension, pulmonary fibrosis, and acute pneumonia). 5. Patients who experienced any Grade 2 or higher toxicities due to prior treatments (as classified by the Common Terminology Criteria for Adverse Events \[CTCAE\] version 5), which have not resolved (excluding anemia, alopecia, and skin pigmentation changes); known or suspected history of hypersensitivity to any of the drugs used in the trial. 6. Pregnant or breastfeeding women.

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Conditions

The condition(s) this trial relates to.

rectal cancer rectal neoplasm rectum adenocarcinoma

As listed by the trial registrant

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

Rectal cancer

Contacts and locations

Locations

  • Jiangsu province hospital

    Nanjing, Jiangsu, 210029, China

  • Nanjing BenQ Hospital

    Nanjing, Jiangsu, 210000, China

  • The Affiliated Hospital of Jiangsu University

    Zhenjiang, Jiangsu, China

  • Xuzhou Central hospital

    Xuzhou, Jiangsu, China

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