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New treatment option for Rectal Cancer
Official title Watch and Wait in PD-1 Monoclonal Antibody Treated dMMR/MSI-H Distal Rectal Cancer
ClinicalTrials.gov ID: NCT04643041
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Preliminary ：
- 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...
- 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)...
You likely can't join if
- Arrhythmia need anti-arrhythmia treatment(except β-blocking agent or Digoxin)，symptomatic coronary heart disease or myocardial ischemia(myocardial...
- 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,
See the full eligibility criteria
- Preliminary ：
- 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...
- 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...
- 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 ：
- 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)
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.