RecruitingNot ApplicableNCT04643041

Watch and Wait in PD-1 Monoclonal Antibody Treated dMMR/MSI-H Distal Rectal Cancer

Watch and Wait in Patients With dMMR/MSI-H Distal Rectal Cancer Accessed Pathological Complete Response After PD-1 Monoclonal Antibody Therapy-an Open Label, Multicenter, Prospective Study (BASKET)


Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Enrollment

47 participants

Start Date

Jan 1, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

Immunotherapy has achieved significant therapeutic effect in DNA mismatch repair-deficient or microsatellite instability-high (dMMR/MSI-H) colorectal cancer (CRC) , more than fifty percent of dMMR/MSI-H CRC patients might get pathological complete response(pCR) after PD-1 monoclonal antibody treatment. For distant rectal cancer(RC), radical resection and neoadjuvant chemotherapy or chemoradiotherapy might cause lots of treatment cost,damage to defecation and sexual function, acute toxicity, chronic dysfunction, even loss of anus and psychological disorder. This study aims to evaluate the effect and safety of watch and wait in patients with dMMR/MSI-H distal RC accessed pCR after PD-1 monoclonal antibody therapy.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is exploring a "watch and wait" approach for patients with a specific type of rectal cancer (dMMR or MSI-H) who achieve a complete clinical response after immunotherapy (anti-PD-1 treatment). Instead of proceeding to surgery after treatment, these patients are closely monitored to see if surgery can be avoided altogether. **You may be eligible if...** - You have been diagnosed with rectal adenocarcinoma confirmed by biopsy - Your cancer has the dMMR or MSI-H genetic marker (a DNA repair defect that makes it respond well to immunotherapy) - Your tumor is in the lower rectum (below the peritoneal reflection) - You have not received any prior cancer treatment - You achieved a complete clinical response after anti-PD-1 immunotherapy **You may NOT be eligible if...** - Your cancer has spread to distant organs - You have a bowel obstruction that cannot be relieved - You have received prior surgery, chemotherapy, or radiation for rectal cancer - You have not responded to immunotherapy treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALwatch and wait

patients with DNA mismatch repair-deficient or microsatellite instability-high distal rectal cancer accessed pathological complete response after 6 courses of PD-1 monoclonal antibody (200mg/Course/Q3w) therapy and start watch and wait.


Locations(1)

Sun Yatsen University

Guangzhou, Guangdong, China

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NCT04643041


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