Phase 2 Colorectal Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have given written consent before any study procedures begin
• Adults aged 18 to 85 years old (male or female)
• People who have been diagnosed with a specific type of rectal cancer (rectal adenocarcinoma) confirmed by a tissue sample (biopsy)
• People whose rectal cancer has reached a certain stage based on scans and camera examination of the bowel — specifically, cancer that has grown beyond the rectal wall, has spread to nearby lymph nodes, or shows certain other concerning features on scans — but has not spread to distant parts of the body, and where surgery is planned after initial treatment
• People whose tumour is located within 15 cm of the opening of the back passage, as measured by scans and bowel camera examination
• People who have at least one tumour that can be measured on scans, according to standard research measurement guidelines
• People who have not previously received any cancer treatment of any kind, including surgery, radiation, chemotherapy, immunotherapy, or targeted therapy
• People who are generally well enough to carry out all normal daily activities, or have only minor limitations (this is measured using a standard fitness scale called the ECOG score of 0 or 1)
• People whose blood test results show that the bone marrow, liver, kidneys, blood clotting system, thyroid, and heart enzymes are all working within acceptable ranges — specific values will be checked by the trial team
• Women who could become pregnant must have a negative pregnancy test within 3 days before the first dose; people who could father or carry a child must use highly effective contraception throughout treatment and for 120 days (or 180 days after chemotherapy) after the last dose

Who may not be able to join:

• People who have had another type of cancer in the last 5 years that has not been fully cured (certain completely removed skin cancers are exceptions)
• People whose rectal cancer has already spread to distant parts of the body (advanced/metastatic disease)
• People who are currently in another clinical trial, or who have received an experimental drug or device within the 4 weeks before joining
• People who have previously been treated with certain types of immune checkpoint therapy (such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or similar drugs)
• People who have received certain traditional Chinese medicines with anti-tumour or immune-modifying properties within the 2 weeks before joining
• People who have had an active autoimmune disease requiring systemic (whole-body) treatment within the past 2 years (hormone replacement for conditions like an underactive thyroid is not considered systemic treatment in this context)
• People who are taking systemic steroid medicines or other immune-suppressing medicines within 7 days before joining (low-dose steroids equivalent to 10 mg or less of prednisone per day may be allowed — confirm with trial site)
• People who have had an organ transplant (other than a cornea transplant) or a stem cell transplant from another person
• People who are known to be allergic to the study drug (Adabelimab) or any of the chemotherapy drugs used in the trial
• People who still have side effects rated above a mild level from any previous medical treatment (with the exception of tiredness or hair loss)
• People who are known to be HIV positive
• People with untreated, active hepatitis B infection with a detectable virus level above the laboratory's normal limit (people with hepatitis B who have lower virus levels may be considered if they receive anti-hepatitis B treatment during the study — confirm with trial site)
• People with active hepatitis C infection where the virus is detectable in the blood
• People who have received a live vaccine within 30 days before the first dose (certain inactivated flu vaccines may be allowed — confirm with trial site)
• Women who are pregnant or currently breastfeeding
• People with serious or uncontrolled health conditions, including but not limited to:
  • Significant heart rhythm problems or certain abnormal heart readings on an ECG
  • Unstable chest pain (angina), heart failure, or moderate-to-severe chronic heart failure
  • A heart attack within the 6 months before joining
  • High blood pressure that is not well controlled (above 140/90 mmHg)
  • A history of lung inflammation requiring steroid treatment in the past year, or currently active lung scarring disease
  • Active tuberculosis
  • An active infection currently needing whole-body (systemic) treatment
  • Active bowel inflammation, abdominal abscess, or bowel blockage
  • Liver disease such as cirrhosis or active hepatitis
  • Poorly controlled diabetes (fasting blood sugar above 10 mmol/L)
  • Significant protein in the urine above a certain level confirmed by testing
  • A mental health condition that would make it difficult to cooperate with treatment
• People with any other medical history, test result, or condition that the trial team believes could affect the results or make participation unsafe

Important: Always verify eligibility with the trial site directly before applying.