Using MRI and blood markers to tell pseudoprogression from real tumor growth after rectal cancer 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 observational study combines multi‑temporal, multiparametric rectal MRI scans with blood biomarkers (IL-8, NLR, LDH, S100) and clinical indicators (KPS, CEA, T-stage) to distinguish pseudoprogression from true progression following immunotherapy. Imaging and blood tests are collected within two weeks before treatment and again at 6 and 12 weeks after starting PD-1/PD-L1 therapy (with or without CTLA-4 inhibitors), and follow-up CT/MRI or pathology (when available) provide reference standards using iRECIST criteria. Eligible patients are biopsy-confirmed stage II–IV rectal cancer cases chosen by an MDT and who are treatment-naïve prior to immunotherapy. The multicenter project is led from Sun Yat-sen University's Sixth Affiliated Hospital with collaboration from Xinyi People's Hospital and aims to identify signatures that could guide clinical decisions about continuing or changing therapy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Rectal cancer confirmed by biopsy pathology;
2. Clinical stage II-IV determined by imaging examinations;
3. Decided by the MDT team to receive immunotherapy (monotherapy with PD-1/PD-L1 inhibitors or in combination with CTLA-4 inhibitors), without prior treatment of any other kind;
4. Multiparametric MRI images of the rectum obtained within 2 weeks before immunotherapy, and at 6 and 12 weeks after treatment;
5. Follow-up CT/MRI data available; evaluation conducted according to the iRECEST criteria, or surgical resection performed to obtain postoperative pathological results, which are necessary for assessing the efficacy of immunotherapy and diagnosing pseudoprogression versus true progression;
6. Blood test parameters (IL-8, NLR, LDH, S100) and clinical indicators (KPS score, CEA level, T-stage) measured within 2 weeks before immunotherapy, and at 6 and 12 weeks after treatment;
7. In cases where imaging suggests disease progression, pathological biopsy or surgical pathology results must be available.
8. The overall survival period is more than 3 months, and the patient does not have any other uncontrollable diseases;
9. The patient has been fully informed and has signed the informed consent form.

Exclusion Criteria:

1. The primary tumor lesion has been surgically removed at the time of initial diagnosis;
2. History of other malignant tumors;
3. Unable to sign informed consent or complete the trial due to physical or psychological illness;
4. Pregnant or lactating women;
5. Those who are allergic to gadolinium-containing contrast agents or contraindicated to undergo enhanced MRI examination, or those who are claustrophobic or have other contraindications to MRI examination and cannot undergo MRI examination;
6. History of autoimmune diseases such as inflammatory bowel disease;
7. Treatment interruption due to serious complications related to immunotherapy.

Where it's running

• Xinyi People's hospital
  Maoming, Guangdong, China Recruiting
• Sixth affiliated hospital, Sun Yat-sen University
  Guangzhou, Guangdong, China Not yet recruiting

Study contacts

• Study coordinator: Peiyi Xie

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Single vs. double stapling and purse-string techniques after rectal cancer surgery

  This trial tests whether using a single-stapling method to join the bowel after rectal cancer surgery results in fewer leaks compared with the double-stapling method.

  Recruiting Alexandria University · Alexandria · NCT07929415

• DEM301 in advanced colorectal cancer: a first-in-human test

  This first-in-human Phase 1 study tests DEM301 in adults with advanced metastatic colorectal cancer to see if it is safe, how it behaves in the body, and whether it shows any signs of activity.

  Recruiting at 2 sites Phase 1 DEM BioPharma, Inc. · Birtinya, Queensland and 1 other locations · NCT07805369

• Rectal cancer registry to track real-world treatments and outcomes

  This registry collects real-world data on how locally advanced rectal cancer is treated in Austria, to see how TNT and dMMR/MSI-H cases are managed and what outcomes occur.

  Recruiting at 2 sites Austrian Breast & Colorectal Cancer Study Group · Wiener Neustadt, Lower Austria and 5 other locations · NCT07780305

• Aerobic exercise and guided imagery for bowel problems after rectal cancer surgery

  This study tests whether a program of aerobic exercise plus guided imagery helps people with low anterior resection syndrome after rectal cancer surgery.

  Recruiting Biruni University · Istanbul · NCT07732894

• Active surveillance vs chemoradiotherapy after local removal of intermediate-risk T1 rectal cancer

  This study tests whether close follow-up alone after local removal of early rectal cancer can match the cancer control of adding chemoradiotherapy, while reducing treatment-related side effects.

  Recruiting at 2 sites Medical University of Gdansk · Limoges and 2 other locations · NCT07669298

• Different-Dose Short-Course Radiotherapy With CAPOX, PD-1 Blockade, and IL-2 in Locally Advanced Rectal Cancer

  This phase II trial tests whether a low-dose short-course radiotherapy combined with CAPOX, a PD-1 blocker, and IL-2 works as well as the standard-dose short-course approach in patients with locally advanced rectal cancer.

  Recruiting Phase 2 The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT07646639

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.