Immune-boosting combo aims to wipe out rectal cancer before surgery

NCT ID NCT05507112

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time

Summary

This study tests whether adding an immunotherapy drug (tislelizumab) to standard chemoradiation before surgery can improve outcomes for people with locally advanced rectal cancer. About 100 participants will receive the combination treatment, and researchers will measure how many achieve a complete response—meaning no cancer cells remain after treatment. The goal is to see if this approach can shrink or eliminate tumors more effectively than standard therapy alone.

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) plus capecitabine and radiation therapy
What this could lead to
If successful, this combination could become a new standard treatment before surgery for locally advanced rectal cancer, potentially increasing the chance of eliminating all cancer cells.
What could go wrong
This is a phase 2 trial with only 100 participants, so results may not apply to everyone. Combining immunotherapy with chemoradiation may increase side effects, and the treatment may not work for all patients.

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

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2022

Expected to finish

Dec 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 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. Age ≥ 18 years and ≤75 years on the day of signing informed consent. 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. 3. Histologically proven rectal adenocarcinoma. 4. \<12 cm from anal verge. 5. Clinical stage of T3/T4 or N positive and M0 6. No previous chemotherapy, radiotherapy, immunotherapy or surgical treatment 7. No immune system disease (e. g. systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), systemic vasculitis, scleroderma, mixed connective tissue disease, dermatomyositis (DM), hyperthyroidism, hypothyroidism, ulcerative colitis (UC), autoimmune hemolytic anemia (AIHA) or human immunodeficiency virus (HIV) infection. 8. Adequate hepatic and renal function to chemoradiotherapy, immunotherapy and surgery. 9. Willing and able to provide written informed consent. Exclusion Criteria: 1. Allergic to any component of chemotherapy or immunotherapy; 2. Patients with multiple primary colorectal cancer; 3. Other malignant tumors within 5 years, except for adequately treated cervical carcinoma in situ or cutaneous basal cell carcinoma, or basically controlled localized prostate cancer or surgically excised ductal carcinoma in situ of breast; 4. Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, or other conditions requiring emergency surgical resection; 5. Prior or planed organ/bone marrow transplant 6. Patients who receive systemic steroid therapy or immunosuppressive agents within 30 days before enrollment in the study; 7. Pregnant or lactating women 8. Patients with a history of severe mental illness or being unable to comply with the research protocols. 9. Patients who have contraindications to chemoradiotherapy, immunotherapy or surgery. 10. Patients who have any other conditions that investigator judges unsuitable to participate.

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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

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730, China

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