Actively Recruiting
Watch and Wait in PD-1 Monoclonal Antibody Treated dMMR/MSI-H Distal Rectal Cancer
Led by Sixth Affiliated Hospital, Sun Yat-sen University · Updated on 2026-04-27
47
Participants Needed
1
Research Sites
312 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Watch and Wait in PD-1 Monoclonal Antibody Treated dMMR/MSI-H Distal Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed rectal adenocarcinoma
- Tumor biopsy showing deficient mismatch repair (dMMR) or microsatellite instability-high (MSI-H)
- MRI showing tumor's lower margin below peritoneal reflection
- Clinical staging TxNxM0 with or without positive mesorectal fascia (MRF) or extramural vascular invasion (EMVI)
- Confirmed absence of distant metastasis by chest and abdominal enhanced CT and pelvic enhanced MRI
- No symptoms of intestinal obstruction or obstruction relieved after proximal colostomy
- No history of rectal surgery
- No prior chemotherapy, radiotherapy, biopharmaceutical, immunotherapy, or other research drug treatments
- Clinical complete response confirmed by imaging
- Pathological complete response confirmed by biopsy
You will not qualify if you...
- Arrhythmia requiring anti-arrhythmia treatment (except beta-blockers or Digoxin)
- Symptomatic coronary heart disease, recent myocardial infarction within 6 months, or congestive heart failure above NYHA grade II
- Severe hypertension not controlled by medication
- HIV infection or active chronic Hepatitis B or C with high viral load
- Active tuberculosis or anti-TB treatment within 1 year
- Other severe active infections
- Evidence of distant metastasis outside the pelvis
- Blood disorders or organ dysfunction
- History of pelvic or abdominal radiotherapy
- Multiple colorectal cancers or multiple primary tumors
- Epilepsy requiring steroid or anti-epilepsy treatment
- History of other malignant tumors within 5 years
- Substance abuse or psychological/social conditions affecting participation
- Active or history of autoimmune diseases
- Recent anti-infection vaccine within 4 weeks
- Long-term use of immune-suppressing drugs or corticosteroids above 10 mg/day prednisolone
- Known or suspected allergy to study drugs
- Any unstable medical condition affecting safety or compliance
- Pregnant or breastfeeding women without contraception
- Refusal to sign informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yatsen University
Guangzhou, Guangdong, China
Actively Recruiting
Research Team
J
Jun Huang, MD
CONTACT
J
Jianping Wang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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