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Can a genetic marker make rectal cancer treatment more precise?
NCT ID NCT06210971
First seen Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time
Summary
This trial is testing whether a combination of chemotherapy drugs (liposomal irinotecan and capecitabine) plus radiation, given before surgery, can help people with locally advanced rectal cancer. The treatment plan is personalized based on a genetic marker (UGT1A1) that affects how the body processes the drugs. The main goal is to see if this approach can lead to a complete disappearance of the tumor 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
- liposomal irinotecan and capecitabine combined with radiation therapy
- What this could lead to
- If successful, this approach could increase the chance of eliminating the tumor before surgery, potentially improving outcomes for rectal cancer patients.
- What could go wrong
- This is an early-phase trial with a small number of participants, so results may not be conclusive. The treatment may cause side effects, and the genetic-guided dosing may not improve outcomes as hoped.
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
-
60 people
The number who actually took part.
- Started
-
Feb 2024
- Expected to finish
-
Jul 2028
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 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: * Age: 18\~75 years old. * Eastern Cooperative Oncology Group (ECOG) performance status of 0\~1. * Histopathologically confirmed rectal adenocarcinoma. * The lower edge of the primary tumor is located below the peritoneal reflection or located ≤ 10 cm above the anal verge. * Clinical stage: T3-4NanyM0 or T1-2N+M0. * Adequate bone marrow function as evidenced by: Absolute neutrophil count (ANC) ≥1.5×10\^9/L, Platelet count ≥100×10\^9/L, Hemoglobin (Hb) ≥90 g/L. * Adequate hepatic function as evidenced by: Total bilirubin ≤1.5 × upper limit of normal (ULN), Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN, Serum albumin ≥3 g/dL. * Adequate renal function as evidenced by: Serum creatinine (Cr) ≤1.5 × ULN or creatinine clearance ≥60 mL/min. * Be willing to undergo UGT1A1 gene testing and UGT1A1 genotype of \*1\*1 or \*1\*28. * Accept the neoadjuvant chemoradiotherapy protocol of this study and sign the informed consent. Exclusion Criteria: * Any other malignancy within 5 years, with the exception of cured in-situ carcinoma or basal cell carcinoma etc. * Active, uncontrolled bacterial, viral, or fungal infections that require systemic treatment. * Active HIV infection. * Combined with uncontrollable systemic diseases. * History of allergy or hypersensitivity to drug or any of their excipients. * Any clinical indicators indicating contraindications to radiotherapy/chemotherapy and surgery. * Use of strong inhibitors or inducers of CYP3A, CYP2C8 and UGT1A1. * Pregnant or breastfeeding women, or subjects of childbearing age who refuse contraception. * Patients with poor cognitive abilities who are unable to answer questions, fill out questionnaires, or have mental disorders. * Patients who do not meet the inclusion criteria; patients who meet the inclusion criteria but are not suitable to participate in this trial judged by the investigator.
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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
-
Hebei Medical University Fourth Hospital
Shijiazhuang, Hebei, 050000, China
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