New drug combo aims to eliminate rectal tumors before surgery
NCT ID NCT07104604
First seen Jul 14, 2026 · Last updated Jul 24, 2026 · Updated 3 times
Summary
This phase 2 trial tests whether adding a new form of chemotherapy (liposomal irinotecan) to standard radiotherapy, immunotherapy (tislelizumab), and another chemotherapy (capecitabine) can make advanced rectal cancers disappear before surgery. The study enrolls adults aged 18–75 with a specific type of locally advanced rectal cancer (pMMR) that has high-risk features. The main goal is to see how many patients achieve complete remission—no sign of cancer after treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a combination of radiotherapy, tislelizumab (an immunotherapy), liposomal irinotecan (a chemotherapy), and capecitabine (a chemotherapy)
- What this could lead to
- If successful, this combination could increase the chance of complete tumor disappearance before surgery, potentially allowing more patients to avoid permanent colostomy and improving long-term outcomes.
- What could go wrong
- This is a small, early-phase trial (51 participants) testing a new drug formulation (liposomal irinotecan) in a specific patient group, so results may not apply broadly. The combination also carries risks of side effects from chemotherapy, immunotherapy, and radiation.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 51 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Jun 2027
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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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.
Here is the updated format for the \*\*Eligibility Criteria\*\* with bullet points for each item: Inclusion Criteria: * Age: 18-75 years, no gender restriction * ECOG score 0-1 * Biopsy-confirmed pMMR (proficient mismatch repair) localized advanced low rectal adenocarcinoma (tumor's lower edge ≤ 10 cm from the anus) * Presence of the following high-risk factors: T3N+/T4/N2/EMVI+/MRF+/lateral lymph node metastasis/inability to undergo sphincter-preserving surgery * Routine chest and abdominal CT scans showing no distant metastasis * Bone marrow function: Neutrophil count (ANC) ≥ 1.5 × 10\^9/L, platelet count (PLT) ≥ 100 × 10\^9/L, hemoglobin (Hb) ≥ 70 g/L * Liver function: ALT, AST ≤ 2.5 × ULN (upper limit of normal); total bilirubin ≤ 1.5 × ULN; serum albumin ≥ 3 g/dL * Kidney function: Serum creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance ≥ 60 ml/min (calculated using the Cockcroft-Gault formula) * For females and patients with reproductive potential, a negative pregnancy test must be done within 72 hours before starting the treatment, and the patient must agree to avoid pregnancy during the study treatment and for 6 months after the treatment. For males with reproductive potential partners, the patient must agree to use adequate medically approved contraception during and for 90 days after the final study treatment * Patients must agree to receive the study's neoadjuvant chemotherapy regimen and sign an informed consent form Exclusion Criteria: * Patients with a history of other malignancies within the past 5 years (except for cured and non-recurring cancers such as in situ carcinoma, basal cell carcinoma of the skin, etc.) * Patients with active, uncontrolled bacterial, viral, or fungal infections requiring systemic treatment, defined by persistent signs/symptoms related to infection, which do not improve despite appropriate antibiotics, antiviral treatments, and/or other therapies * Patients with uncontrolled systemic diseases, including unstable angina, myocardial infarction, congestive heart failure, severe unstable ventricular arrhythmia, history of severe pericardial disease, or other cardiovascular diseases; uncontrolled hypertension (defined as systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg despite appropriate antihypertensive treatment), or a history of hypertensive crisis, hypertensive encephalopathy; uncontrolled diabetes (fasting blood glucose ≥ 10 mmol/L), etc. * Patients known to be allergic or intolerant to the treatment drugs or excipients used in this study * Any clinical indicators showing contraindications to chemotherapy and surgery * Patients using strong inhibitors or inducers of enzymes such as CYP3A4, CYP2C8, and UGT1A1 * Pregnant or breastfeeding women, and female patients of reproductive potential who refuse to use appropriate contraceptive measures during the study * Patients who participated in other clinical trials within 4 weeks before enrollment * Patients whom the investigator deems unsuitable for participation in the study
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Shantou University Medical College Cancer Hospital
RECRUITINGShantou, Guangdong, 515000, China
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The First Affiliated Hospital of Shantou University Medical College
NOT_YET_RECRUITINGShantou, Guangdong, 515041, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A phase II study of total neoadjuvant mFOLFOX6 plus suvemcitug and enlonstobart with selective omission of pelvic radiotherapy for High-Risk Mid-Rectal locally advanced rectal cancer with MSS status
- Leveraging digital health solutions to collect Patient-Reported outcomes in rectal cancer
- Can a targeted drug conjugate outsmart advanced colorectal cancer?
- Can a platform trial match the right drug combo to each tumor?
- Laser light may help surgeons spot risky bowel connections
- Can a counseling program restore intimacy after rectal cancer?