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Condition Guide

New Treatments & Clinical Trials for Rectal Cancer

Last updated August 2026Data from ClinicalTrials.gov0 active trials
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Rectal cancer treatment typically involves surgery, often combined with radiation and chemotherapy. About 45,000 people are diagnosed with rectal cancer in the U.S. each year. Recent advances include organ-preserving approaches for some patients and immunotherapy for tumors with certain genetic markers.

What's actually going on in research

Trials are testing whether radiation or even surgery can be avoided in patients whose tumors respond completely to chemotherapy. Immunotherapy with checkpoint inhibitors like pembrolizumab works remarkably well for tumors with mismatch repair deficiency. Researchers are also studying new chemotherapy combinations, targeted drugs for specific mutations, and ways to predict which patients need intensive treatment.

Total neoadjuvant therapy

Giving all chemotherapy and radiation before surgery — rather than some after — appears to increase the chance that tumors disappear completely. Some patients with complete responses may be able to avoid surgery entirely through careful monitoring.

Immunotherapy for MMR-deficient tumors

About 5-10% of rectal cancers have mismatch repair deficiency, making them highly responsive to checkpoint inhibitors. Studies now show that immunotherapy alone can eliminate these tumors before surgery, potentially sparing patients from chemotherapy and radiation.

Organ preservation

Trials are defining which patients whose tumors shrink completely with treatment can safely skip surgery. This watch-and-wait approach requires close monitoring but preserves bowel function and quality of life.

What to know before you search

Eligibility typically depends on tumor stage, distance from the anal verge, prior treatments, mismatch repair status, and whether metastases are present.

What types of trials are currently open

  • Neoadjuvant treatment trialsTesting chemotherapy, radiation, or immunotherapy given before surgery to shrink tumors. Some studies explore whether patients with complete responses can avoid surgery.
  • Targeted therapy trialsTesting drugs aimed at specific mutations like KRAS, BRAF, or HER2 that drive some rectal cancers.
  • Immunotherapy trialsTesting checkpoint inhibitors, often in tumors with mismatch repair deficiency or high mutation burden.
  • Surgical trialsComparing different surgical techniques or studying minimally invasive approaches like robotic surgery.
  • Quality of life studiesFollowing patients to understand long-term bowel, sexual, and urinary function after treatment.

Recently added Rectal Cancer trials

RecruitingObservational study

Guaraná Supplementation for Cancer-Related Fatigue

Cancer-related fatigue is one of the most common and distressing symptoms experienced by patients during and after cancer treatment, and current options to manage it are limited. Guaraná (Paullinia cupana), an Amazonian plant rich in caffeine and other methylxanthines with anti-inflammatory and central-nervous-system-stimulating properties, has shown preliminary benefit for fatigue in small studies but lacks robust evidence. This pragmatic, prospective, single-arm study will evaluate whether guaraná supplementation reduces chronic cancer-related fatigue and improves quality of life in 60 patients with breast, lung, colorectal, or gastric cancer receiving active systemic treatment. Participants will take a 50 mg guaraná capsule by mouth every 12 hours for up to six 21-day cycles. The main outcome is the change in fatigue (baseline vs. post-intervention) measured with the FACIT-F and the Brief Fatigue Inventory (BFI). Secondary outcomes include quality of life (EORTC QLQ-C30) and adverse events. The study aims to support guaraná as a safe, accessible complementary option in supportive cancer care.

Bogotá, Bogota D.C., Colombia
RecruitingSafety & dosing

SKL35501 With SKL35502 Imaging in Adults With NTSR1 Positive Advanced Solid Tumors

This Phase 1, open-label study will evaluate two investigational radiopharmaceuticals in adults with selected advanced or metastatic solid tumors. SKL35502 is an imaging agent used with SPECT scans to identify tumors with neurotensin receptor 1 (NTSR1), a protein found on some cancer cells, and to assess where the agent travels in the body and the radiation dose delivered to tissues. Participants with sufficient SKL35502 tumor uptake may receive SKL35501, a treatment designed to deliver targeted alpha radiation to NTSR1-expressing tumor cells. Part A will evaluate the safety and imaging performance of SKL35502 and the safety, tolerability, pharmacokinetics, biodistribution, dosimetry, and biologically active dose range of SKL35501, as well as preliminary antitumor activity. Part B will further evaluate selected SKL35501 dose levels, including randomized low- and high-dose groups in participants with colorectal cancer, and will expand evaluation in selected tumor types. The study will also examine relationships among SKL35502 imaging, NTSR1 expression, SKL35501 tumor uptake, and treatment outcomes.

Glen Burnie, Maryland, United States +4 more
See all recruiting Rectal Cancer trials →

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