Clinical Trials for Rectal Cancer

A Randomized Phase III Study of Systemic Therapy With or Without Hepatic Arterial Infusion for Unresectable Colorectal Liver Metastases: The PUMP Trial

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

HealthScout AI summary: Adults with unresectable, liver-only metastatic colorectal cancer (after 3–6 months of first-line chemotherapy, ECOG 0-1, no significant extrahepatic disease) are randomized to standard systemic chemotherapy (e.g., FOLFOX, FOLFIRI, or OX/IRI ± targeted agents) with or without hepatic arterial infusion of floxuridine, an antimetabolite delivered directly to the liver via an implanted pump.

ClinicalTrials.gov ID: NCT05863195

Phase II Study Evaluating the Efficacy of PDS01ADC in Combination With Hepatic Artery Infusion Pump (HAIP) and Systemic Therapy for Subjects With Metastatic Colorectal Cancer, Intrahepatic Cholangiocarcinoma, or Metastatic Adrenocortical Carcinoma

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

HealthScout AI summary: This trial enrolls adults with liver-only or liver-dominant metastatic colorectal cancer, intrahepatic cholangiocarcinoma, or adrenocortical carcinoma who have progressed on prior chemotherapy, and treats them with hepatic artery infusion pump (HAIP) floxuridine-based chemotherapy plus standard systemic therapy and PDS01ADC, an investigational IL-12–based immunocytokine targeting necrotic tumor regions to enhance local immune activation. Cohorts are separated by tumor type.

ClinicalTrials.gov ID: NCT05286814

A Phase 1 Study of 5-Fluorouracil in Combination With Abemaciclib in Metastatic, Refractory CRC

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

HealthScout AI summary: This trial enrolls adults with microsatellite stable (MSS) metastatic colorectal cancer refractory to standard therapies, testing the combination of oral abemaciclib (a selective CDK4/6 inhibitor that blocks cell cycle progression) with intravenous 5-fluorouracil. Prior CDK4/6 inhibitor use and intolerance to fluoropyrimidines are exclusion criteria.

ClinicalTrials.gov ID: NCT06654037

Phase I Trial of 5-Fluorouracil (5FU) -Based Therapy in Combination With Hydroxytyrosol (HT) in Patients With Advanced or Metastatic Colorectal Cancer

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

HealthScout AI summary: This study enrolls adults with advanced or metastatic colorectal cancer (excluding dMMR/MSI-H) who are candidates for first-line 5-FU-based chemotherapy (FOLFIRI or FOLFOX ± biologics), testing the addition of oral hydroxytyrosol—a polyphenol with preclinical anti-inflammatory and immune modulatory effects—to standard treatment. Eligibility requires ECOG 0–1, measurable disease, and adequate organ function.

ClinicalTrials.gov ID: NCT06833866

Phase II Study of Hypofractionated Radiation Therapy to Augment Immune Response in Patients With Metastatic GastroIntestinal Malignancies Progressing on Immune Therapy (ARM-GI)

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

HealthScout AI summary: This trial enrolls adults with metastatic gastrointestinal cancers (including esophageal, gastric, small intestine, hepatocellular, pancreaticobiliary, colorectal, or anal) who are progressing on a checkpoint or CTLA-4 inhibitor, treating them with hypofractionated external beam radiation (30 Gy in 5 fractions to 1-5 lesions) in addition to ongoing immunotherapy. The aim is to determine if radiation can enhance systemic immune response and improve outcomes in this refractory population.

ClinicalTrials.gov ID: NCT04221893

A Phase I Study of Intraperitoneal 5FU+Oxaliplatin in Patients with Colorectal Cancer with Isolated Peritoneal Metastasis

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

HealthScout AI summary: This trial enrolls adults with biopsy-proven colorectal cancer and isolated peritoneal metastases (PCI >20), without prior cytoreductive surgery, who receive intraperitoneal oxaliplatin and 5FU via a peritoneal port. It is designed to assess safety, tolerability, and dose parameters of this locoregional chemotherapy approach.

ClinicalTrials.gov ID: NCT06269978

A Multicenter Phase 1b/2 Study of Adagrasib, Cetuximab, and Cemiplimab for Metastatic Colorectal Cancer Harboring KRAS G12C Mutations

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

HealthScout AI summary: Adults with advanced or metastatic, microsatellite stable colorectal cancer harboring a KRAS G12C mutation who have progressed on at least one prior line of chemotherapy are eligible for combination therapy with adagrasib (a selective KRAS G12C inhibitor), cetuximab (anti-EGFR antibody), and cemiplimab (PD-1 inhibitor). Prior exposure to KRAS G12C or immune checkpoint inhibitors is excluded.

ClinicalTrials.gov ID: NCT06412198

An Open-label Randomized Phase 3 Study of Tucatinib in Combination With Trastuzumab and mFOLFOX6 Versus mFOLFOX6 Given With or Without Either Cetuximab or Bevacizumab as First-line Treatment for Subjects With HER2+ Metastatic Colorectal Cancer

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

HealthScout AI summary: This trial enrolls adults with previously untreated, HER2-positive, RAS wild-type metastatic colorectal cancer to compare standard first-line mFOLFOX6-based regimens versus mFOLFOX6 combined with trastuzumab and tucatinib, a selective oral HER2 tyrosine kinase inhibitor. Eligible patients may have stable, treated brain metastases.

ClinicalTrials.gov ID: NCT05253651

An Open-label, Randomized, Multi-Center Study to Evaluate the Efficacy and Safety of Induction Treatment With Melphalan/HDS Followed by Consolidation Treatment With Trifluridine-Tipiracil Plus Bevacizumab Versus Trifluridine-Tipiracil Plus Bevacizumab Alone in Patients With Refractory Metastatic Colorectal Cancer With Liver Dominant Disease

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

HealthScout AI summary: Adults with refractory metastatic colorectal cancer and liver-dominant disease (≤50% liver involvement; limited extrahepatic disease allowed; ECOG 0–1) are randomized to induction hepatic-directed high-dose melphalan via the Delcath system (regional chemotherapy that isolates hepatic circulation to intensify cytotoxic exposure) followed by trifluridine–tipiracil plus bevacizumab, versus trifluridine–tipiracil plus bevacizumab alone. Prior exposure to fluoropyrimidine, oxaliplatin, irinotecan, anti-VEGF, and anti-EGFR (if RAS WT) is required; key exclusions include significant hepatic dysfunction, portal/venous thrombosis, major cardiopulmonary comorbidity, prior arterial liver-directed therapy, and peritoneal disease.

ClinicalTrials.gov ID: NCT06607458

A Randomized Phase 2 Trial of Flat Dose vs. Weight-based Dose of Intra-peritoneal (IP) Chemotherapy for Patients Undergoing Cytoreductive Surgery and Heated Intra-peritoneal Chemotherapy (CRS/HIPEC) for Advanced Gastrointestinal Malignancy

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

HealthScout AI summary: Adults with peritoneal carcinomatosis from colorectal or appendiceal primaries undergoing cytoreductive surgery are randomized to HIPEC mitomycin C given as a fixed total dose (40 mg) versus weight-based dosing (12.5 mg/m2). Both arms use mitomycin C, a DNA crosslinking cytotoxic antibiotic, with the study focused on pharmacokinetics and potential reduction of systemic exposure/toxicity.

ClinicalTrials.gov ID: NCT04779554