New cocktail aims to make immunotherapy work for common colorectal cancer
NCT ID NCT04895137
First seen Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time
Summary
This phase 2 trial is testing whether a combination of chemotherapy (mFOLFOX6), a targeted therapy (bevacizumab), and an immunotherapy (PD-1 inhibitor) can help people with a specific type of locally advanced colorectal cancer called microsatellite stable (MSS). Unlike other colorectal cancers, MSS tumors usually do not respond to immunotherapy alone. The study includes about 42 participants with stage T4NxM0 disease, where the tumor is growing through the bowel wall and may involve nearby lymph nodes. The main goal is to see if this combination can lead to a complete disappearance of the cancer at the time of surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- mFOLFOX6, bevacizumab, and sintilimab (a PD-1 inhibitor)
- What this could lead to
- If successful, this combination could offer a new treatment option for patients with a common type of colorectal cancer that typically does not respond to immunotherapy alone.
- What could go wrong
- This is an early phase 2 trial with only 42 participants, so results may not apply to all patients. The combination therapy may cause significant side effects, and it is not yet known if it improves long-term outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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42 people
The number who actually took part.
- Started
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May 2021
- Finished
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Sep 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Histological identified colon and upper rectum adenocarcinoma, Tumor biopsy immunohistochemical (IHC) identified pMMR, including all of the MSH1,MSH2,MSH6 and PMS2 protein expression and diagnosed as proficient mismatch repair(pMMR), or next generation sequencing identified (MSS); MRI identified tumor inferior margin higher than peritoneal reflection, * Clinical staging T4NxM0, with or without positive MRF, with or without positive EMVI, * Staging method:all patients undergo chest,abdominal and pelvic enhanced CT, rectal palpation, high resolution MRI 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, 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Sun Yatsen University
Guangzhou, Guangdong, China
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Other studies related to the condition(s) this trial covers.
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