Immune-boosting combo aims to wipe out rectal cancer before surgery
NCT ID NCT05507112
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
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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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
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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 Hide 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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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