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Chemotherapy + Immunotherapy for Rectal Cancer
Study Summary
This trial is testing whether adding low-dose chemotherapy and/or immunotherapy to standard radiation therapy can improve outcomes in patients with locally advanced rectal cancer.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2023 Phase 2 trial • 27 Patients • NCT04002401Trial Design
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- I have had radiation therapy to the chest area before.I have not had major surgery within the last 28 days.You have participated in a study involving durvalumab or tremelimumab before, no matter which treatment you received.I have or had an autoimmune or inflammatory disorder.My doctor thinks I can undergo surgery and combined treatment.My cancer has spread to distant parts of my body, including possibly the brain or spine.I have tested positive for HIV or have active tuberculosis.I don't have lasting side effects from cancer treatment, except for hair loss or skin changes.I have mesothelioma and have not received any treatment for it.I do not have an active hepatitis infection.I have not received a live vaccine in the last 30 days.I weigh more than 30 kilograms.I haven't taken immunosuppressive drugs in the last 14 days.I am not currently on any cancer treatments like chemotherapy or hormone therapy.I am not pregnant or breastfeeding and agree to use birth control during and after treatment.I have received an organ transplant from another person.My cancer is at stage I, II, or III based on specific scans.I am willing and able to follow the study's treatment plan and attend all visits.I have nerve damage that affects my daily activities.I have a severe side effect that won't worsen with durvalumab or tremelimumab, as confirmed by a study doctor.I have had cancer before.I have had cancer spread to the lining of my brain and spinal cord.You have a history of a current weakened immune system.I am 18 years old or older.I have a serious illness like heart or lung disease that prevents me from getting radiation therapy.I do not have any unmanaged ongoing illnesses.I have had a brain scan with contrast before joining the study.Your heart's electrical activity (QT interval) is longer than normal when measured on multiple ECG tests.I am fully active or can carry out light work.My condition is confirmed mesothelioma through tissue analysis.My organs and bone marrow are functioning well.You are expected to live for at least 12 weeks.My tumor can be safely biopsied.
- Group 1: Radiation alone (Arm B)
- Group 2: Radiation+Drug (Arm A)
- Approved for 20 Other Conditions - This treatment demonstrated efficacy for 20 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is the age qualification for this research higher than 25 years?
"The acceptable age range for participants is 18 to 95, as stipulated in the clinical trial's inclusion rules."
Is Cyclophosphamide a feasible treatment option with minimal hazards?
"Cyclophosphamide was deemed to have a safety rating of 2, as it is currently undergoing Phase 2 testing. This indicates there are some data points supporting the drug's safety but no evidence yet for its efficacy."
Is my eligibility to join this medical experiment sufficient?
"This research trial is recruiting 30 individuals with malignant mesothelioma ranging in age from 18 to 95. The primary eligibility criteria include: serum bilirubin ≤1.5 x institutional upper limit of normal (ULN), capacity for informed consent and compliance, an Eastern Cooperative Oncology Group performance score of 0 or 1, body weight greater than 30 kg, haemoglobin ≥9.0 g/dL , ANC ≥1.0 × 109 /L, platelet count ≥75 × 109/L, AST (SGOT)/ALT (SGPT) ≤2.5x ULN unless liver metastases"
What is the cap for the amount of participants joining this clinical investigation?
"Yes, the clinical trial is still open for enrollment. According to records on clinicaltrials.gov, this research endeavor was initially posted online on May 9th 2022 and has been recently updated as of May 13th 2022. It requires 30 participants from a single site in order to proceed."
Are there any available opportunities for participation in this trial?
"According to clinicaltrials.gov, this medical research is actively recruiting participants. The trial was initially posted on May 9th 2022 and has since been updated as recently as the 13th of that same month."
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