New combo therapy aims to shrink rectal tumors and save sphincters
NCT ID NCT06493240
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tested whether adding a PD-1 inhibitor (Sintilimab) after standard chemoradiotherapy could improve outcomes for 30 patients with locally advanced mid-low rectal cancer. Participants received radiation and chemotherapy, then three doses of Sintilimab, followed by surgery. The study measured how many patients had a complete tumor disappearance and how many could keep their anal sphincter.
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 inhibitor) combined with capecitabine-based chemoradiotherapy
- What this could lead to
- If successful, this combination could increase the chance of eliminating the tumor before surgery and help more patients avoid permanent colostomy.
- What could go wrong
- This is a small, early-phase trial with only 30 participants, so results may not apply broadly. Immune-related side effects from the PD-1 inhibitor are possible.
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
-
30 people
The number who actually took part.
- Started
-
Jan 2023
- Finished
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Apr 2025
- 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
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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: * aged 18\~75 * ECOG score 0\~2 * biopsy diagnosed rectal adenocarcinoma, distal margin within 10cm to anal verge * no distant metastasis, staged II/III (T4b excluded) by MRI * maximum diameter of rectal cancer lesion≥10mm according to baseline CT or MR * willing and able to comply with study protocol * consent to the use of blood and tissue specimens for study * no history of previous anti-tumor treatment (e.g. radiation, chemo, immuno, bio, herbal, etc.) * no disorders/diseases of immune system (e.g. systemic lupus erythematosus, rheumatoid arthritis, systemic vasculitis, scleroderma, pemphigus, dermatomyositis, mixed connective tissue disease, autoimmune hemolytic anemia, hyperthyroidism/hypothyroidism, ulcerative colitis, autoimmune hemolytic anemia, HIV infection, etc.) * no significant dysfunction of major viscera (e.g. heart, lung, liver, kidney, etc.) * no jaundice or gastrointestinal obstruction * no acute/ongoing infection * no significant irregularities in blood routine test and biochemical test results, particular requirements include: neutrophils≥1.5×109/L, HGB≥80g/L, platelet≥100×109/L, serum creatinine≤1.5×ULN, total bilirubin≤1.5×ULN, ALT、AST≤2.5×ULN * no social or mental disorder * for women of child-bearing age, a negative result of serological pregnancy test is required, and effective contraception measures from inclusion till 60 days after the last dose of study drug is required Exclusion Criteria: * multiple cancers, or with concomitant malignant tumors besides rectal cancer * having received any anti-cancer treatment (surgery, drugs, etc.) in the past 5 years * history of recent major surgery * with condition that affects the absorption of capecitabine via gastrointestinal tract (e.g. inability to swallow, nausea, vomiting, chronic diarrhea, etc.) * with uncontrolled, severe, concomitant diseases of any sort * allergic to any of the ingredients under study * estimated survival ≤ 5 years due to any reason * preparing for or having previously received organ or bone marrow transplant * having received immunosuppressive or systemic hormone therapy for immunosuppressive purposes within 1 month prior to inclusion * for patients with history of disorder of central nervous system, investigator discretion is required as to whether the clinical severity prevents the signing of informed consent or affects the patient or oral medication compliance * with other conditions/issues that may affect the study results or cause the study treatment to be terminated halfway (e.g. alcoholism, drug abuse, etc.) * pregnant or lactating women, or women intending on conception during treatment period
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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 University People's Hospital
Beijing, Beijing Municipality, 100044, China
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Other studies related to the condition(s) this trial covers.
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