A Phase III Trial of Anus-preservation in Low Rectal Adenocarcinoma Based on MMR/MSI Status

Launched by ZHEJIANG CANCER HOSPITAL · Dec 29, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating how to treat low rectal cancer while preserving the anus, which is important for many patients. Researchers are looking at two groups: those with a specific gene status called dMMR/MSI-H, and those with a different status called pMMR/MSS. Patients with dMMR/MSI-H will either receive immunotherapy (a type of treatment that helps the immune system fight cancer) or a combination of radiation therapy followed by immunotherapy. Those with pMMR/MSS will first receive a type of chemotherapy along with radiation before being placed in one of two treatment groups. The main goals of the study are to see how many patients have a complete response to treatment that lasts for at least one year, as well as to assess long-term outcomes and any side effects.

To be eligible for this trial, participants need to be between 18 and 70 years old and have a confirmed diagnosis of adenocarcinoma (a type of cancer). They should also have a strong desire to keep their anus and not have any distant spread of the cancer. Additionally, they must be able to follow the treatment plan and attend follow-up appointments for at least two years. It's important to note that certain health conditions or treatments could exclude someone from participating. If you or a loved one is interested in this trial, it could be a promising option to consider for treatment while aiming to maintain quality of life.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. pathological confirmed adenocarcinoma；
• • 2. clinical stage T2-4 and/or N+，Not suitable for initial local excision to achieve radical treatment；
• • 3. the distance from anal verge less than ≤ 5cm，or surgical evaluation concludes that direct surgical anal preservation is not possible without distance metastases；
• • 4. age 18-70 years old, female and male；
• • 5. Strong desire for anal preservation and ability to be closely monitored for at least 2 years after chemoradiotherapywith good compliance；
• • 6. without distant metastases；
• • 7. ECOG Performance status 0-1；
• • 8. Detection of UGT1A1\*6 and \*28 gene status (for pMMR patients)；
• • 9. Sufficient bone marrow reserve and physical capacity to receive consolidation chemotherapy after chemoradiotherapy (for pMMR patients)；
• • 10. with good compliance；
• • 11. signed the inform consen.
• Exclusion Criteria:
• • 1. pregnant or breastfeeding women；
• • 2. Persons with a history of uncontrolled epilepsy, central nervous system disorders, or psychiatric disorders whose clinical severity, as judged by the investigator, may prevent the signing of informed consent or affect the patient's compliance with oral medications；
• • 3. Difficult to achieve complete remission at the available level of evidence, such as: tumor largest diameter \>10 cm; largest diameter of lateral lymph nodes \>2 cm; baseline CEA \>= 100; biopsy pathology with an indolent cell carcinoma component; tumor of circumferential narrowing type on anal finger examination, with inclusion decided by the judgment of the evaluation team if necessary；
• • 4. Clinically significant (i.e., active) heart disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) class II or worse congestive heart failure or severe arrhythmias requiring pharmacological intervention, or a history of myocardial infarction within the last 12 months；
• • 5. persons requiring immunosuppressive therapy for organ transplantation；
• • 6. Persons with severe uncontrolled recurrent infections, or other severe uncontrolled concomitant diseases；
• • 7. Subjects with baseline routine blood and biochemical indicators do not meet the following criteria: hemoglobin ≥ 90g/L; absolute neutrophil count (ANC) ≥ 1.5×109/L; platelets ≥ 100×109/L; ALT, AST ≤ 2.5 times the upper limit of normal; ALP ≤ 2.5 times the upper limit of normal; serum total bilirubin \< 1.5 times the upper limit of normal; serum creatinine \< 1 times the upper limit of normal limit; serum albumin ≥30g/L；
• • 8. Known to have dihydropyrimidine dehydrogenase (DPD) deficiency；
• • 9. allergic to any investigational drug component.