Watchful waiting for patients with specific rectal cancer after immunotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and effectiveness of a watch and wait approach for patients with distal rectal cancer who have achieved a pathological complete response after treatment with PD-1 monoclonal antibodies. The focus is on patients with DNA mismatch repair-deficient or microsatellite instability-high rectal cancer, aiming to avoid the complications associated with radical surgery and chemotherapy. By monitoring patients instead of proceeding with immediate surgery, the study seeks to minimize treatment-related side effects while assessing long-term outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Preliminary inclusion criteria：

* Histological identified rectal adenocarcinoma,
* Tumor biopsy immunohistochemical (IHC) identified dMMR, including one or more deficient of the MSH1,MSH2,MSH6 and PMS2 protein expression and diagnosed as deficient mismatch repair(dMMR), or next generation sequencing identified (MSI-H)； MRI identified tumor inferior margin lower than peritoneal reflection,
* Clinical staging TxNxM0, with or without positive MRF, with or without positive EMVI,
* Staging method：all patients undergo rectal palpation, high resolution MRI ± transrectal Ultrasound examination，positive perienteric lymph node(LN): short diameter ≥10mm LN or LN with typical metastatic shape and MRI character, clinical data should be re-evaluated and judged by center evaluation group when there are contradictory stagings，distant metastasis were excluded by chest and abdominal enhanced CT and pelvic enhanced MRI,
* No intestinal obstruction symptom，or obstruction relieved after proximal colostomy,
* No rectal surgery history,
* No chemotherapy or radiotherapy history,
* No biopharmaceutical treatment history(such as monoclonal antibody), immunotherapy(such as anti PD-1antibody, anti PD-L1 antibody, anti PD-L2 antibody or anti CTLA-4), or other research drug treatment,
* Endocrinotherapy history restriction:No
* Informed consent assigned, Final inclusion criteria：
* Clinical complete response (cCR)(Chest,abdominal and pelvic enhanced CT or pelvic enhanced MRI or transrectal ultrasound proved)
* Transrectal ultrasound biopsy or endoscopic biopsy proved pathologically complete response (pCR)

Exclusion Criteria:

* Arrhythmia need anti-arrhythmia treatment(except β-blocking agent or Digoxin)，symptomatic coronary heart disease or myocardial ischemia(myocardial infarction within 6 months) or congestive heart-failure (CHF) \> NYHA grade II,
* Severe hypertension not well controlled by drugs,
* HIV infection history or active phase of chronic Hepatitis B or C(high copies of virus DNA),
* Active tuberculosis(TB)，accepting anti-TB treatment or anti-TB treatment within 1 year before trial screen,
* Other active clinical severe infection(NCI-CTC V5.0),
* Outside pelvic distant metastasis evidences,
* Dyscrasia, organ dysfunction,
* Pelvic or abdominal radiotherapy history,
* Multiple CRC or Multi-primary tumors；
* Epilepsy need treatments(Steroid or anti-epilepsy therapy),
* Other malignant tumor history within 5 years,
* Over abuse of drugs, medical and psychological or social conditions that might interfere patients or evaluation of the study results,
* Any active autoimmune disease or autoimmune disease history (including but not restricted：interstitial pneumonia, uveitis,enteritis, hepatitis,hypophysitis, nephritis, hyperthyroidism, hypothyroidism, asthma need bronchodilators),
* Any anti-infection vaccine injection 4 weeks before inclusion ,
* Long-term exposure to immune-suppressor, combination of systemic or topical use of corticosteroids (dose\>10mg/day prednisolone or equivalent hormone)；
* Known or suspicious allergy to any study related drugs,
* Any unstable state might cause damage to the safety and compliance of patients,
* Pregnant or breast feeding women who has ability to have children while without contraception,
* Refuse to sign informed consent

Where it's running

• Sun Yatsen University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Jun Huang, MD
• Email: huangj97@mail.sysu.edu.cn
• Phone: +8613926451242

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.