Neoadjuvant treatment for rectal cancer using specific chemotherapy based on genetic testing

Exploratory Study on the Efficacy and Safety of Long-course Neoadjuvant Chemoradiation With Liposomal Irinotecan and Capecitabine Guided by UGT1A1 Status in Patients With Locally Advanced Rectal Cancer

This study is testing a new chemotherapy treatment for people with locally advanced rectal cancer to see if using genetic testing to guide the treatment makes it safer and more effective.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Hebei Medical University Fourth Hospital (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Shijiazhuang, Hebei)
• Trial ID: NCT06210971 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness and safety of a neoadjuvant treatment regimen combining liposomal irinotecan and capecitabine, guided by UGT1A1 genetic status, in patients with locally advanced rectal cancer. It is a single-center, single-arm study that aims to assess both short-term and long-term outcomes, including patients' nutritional status, quality of life, symptom changes, and adverse events throughout the treatment process. Participants will receive comprehensive monitoring and prompt intervention for any adverse symptoms during the study.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with histologically confirmed locally advanced rectal adenocarcinoma and specific UGT1A1 genotypes.

Not a fit: Patients with rectal cancer who do not meet the genetic testing criteria or have advanced metastatic disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved treatment outcomes and quality of life for patients with rectal cancer.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in using genetic testing to guide chemotherapy regimens in cancer treatment.

Eligibility criteria

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.

Where this trial is running

Shijiazhuang, Hebei

• Hebei Medical University Fourth Hospital — Shijiazhuang, Hebei, China (RECRUITING)

Study contacts

• Principal investigator: Fengpeng Wu, Professor — Hebei Medical University Fourth Hospital
• Study coordinator: Linlin Xiao, Ms.

Conditions: Rectal Cancer, UGT1A1, liposomal irinotecan, total neoadjuvant therapy