Clinical Trials for Rectal Cancer

A Randomized Phase 2 Trial of Fruquintinib and TAS-102 as Compared to Fruquintinib in Patients With Refractory Advanced/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.

TrialFetch AI summary: Enrolling adults with ECOG 0–1, measurable, mismatch repair–proficient/microsatellite-stable advanced/metastatic colorectal adenocarcinoma that has progressed on or is intolerant to standard metastatic CRC therapies (fluoropyrimidine, oxaliplatin, irinotecan, bevacizumab, and anti-EGFR for RAS wild-type), excluding MSI-H/dMMR, BRAF V600, and prior regorafenib/TAS-102/fruquintinib. Patients are randomized to fruquintinib (oral selective VEGFR-1/2/3 TKI anti-angiogenic) plus TAS-102 (trifluridine/tipiracil DNA-directed cytotoxic) versus fruquintinib alone.

ClinicalTrials.gov ID: NCT06992258

Phase II Trial of 5-Fluorouracil (5FU)-Based Therapy in Combination With Fruquintinib as First Line in Patients With Locally Advanced Unresectable or 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.

TrialFetch AI summary: Adults with locally advanced unresectable or metastatic colorectal cancer (RECIST-measurable, ECOG 0–1) who have not received prior systemic therapy for advanced disease (including recurrent disease after resection without prior systemic therapy). Patients receive first-line FOLFIRI or mFOLFOX6 combined with fruquintinib, an oral selective VEGFR-1/2/3 tyrosine kinase inhibitor (anti-angiogenic) dosed days 1–21 of a 28-day cycle, with maintenance 5-FU plus fruquintinib after ~6 months in those with at least stable disease.

ClinicalTrials.gov ID: NCT07042685

A Phase 1 Multicenter Study Evaluating the Safety and Tolerability of GCC19CART for Subjects With Relapsed or Refractory Metastatic Colorectal Cancer

Active drug

Investigational drug(s) in this trial have shown anticancer activity 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.

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.

TrialFetch AI summary: Adults with relapsed/refractory metastatic colorectal cancer that is GCC (GUCY2C)–positive by IHC, previously treated with fluoropyrimidine/oxaliplatin/irinotecan and appropriate biologics (anti-VEGF and anti-EGFR if RAS WT), with measurable extracranial disease and limited liver tumor burden (<7 lesions, largest <3 cm) and no curative surgical option. Patients undergo leukapheresis and receive a single infusion of autologous GCC19CART (LYL273), a GCC-targeted CAR T-cell therapy using a coupled GCC CAR plus CD19 CAR component intended to enhance activation/expansion in solid tumors.

ClinicalTrials.gov ID: NCT05319314

Evaluation of Circulating Immune Response After Histosonics in Colorectal Cancer (ECHO-CRC)

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.

TrialFetch AI summary: Enrolling adults with biopsy-confirmed metastatic microsatellite-stable colorectal cancer and at least one radiographically evident liver metastasis who are planned for standard-of-care histotripsy (ECOG 0–3, adequate organ function). Patients receive noninvasive focused ultrasound histotripsy (mechanical tumor disruption via acoustic cavitation) to one or more liver metastases with serial blood draws pre/post procedure to assess systemic immune modulation (T-cell clonal expansion and exhaustion markers).

ClinicalTrials.gov ID: NCT07361107

Phase II Study of Liposomal Irinotecan With TAS102 and Bevacizumab for Patients With 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.

TrialFetch AI summary: Single-arm study for adults with ECOG 0–1, mismatch repair-proficient metastatic/unresectable colorectal adenocarcinoma refractory to fluoropyrimidine, oxaliplatin, and irinotecan-based therapy, with prior anti-EGFR and HER2-targeted therapy required when applicable. Treatment is liposomal irinotecan, a nanoliposomal topoisomerase I inhibitor/SN-38 delivery formulation, plus TAS-102 (trifluridine/tipiracil) and bevacizumab.

ClinicalTrials.gov ID: NCT05854498

An Open Label Phase II Study for the Treatment of Liver Metastatic Colorectal Cancer and Non-Small Cell Lung Cancer With a Combination of TATE (Trans-Arterial Tirapazamine Embolization) and Pembrolizumab

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.

TrialFetch AI summary: This trial evaluates the combination of Trans-Arterial Tirapazamine Embolization (TATE) and Pembrolizumab in patients with metastatic colorectal cancer (mCRC) and non-small cell lung cancer (NSCLC) who have liver metastases and have progressed after prior therapies. TATE delivers the hypoxia-activated prodrug Tirapazamine to liver tumors, while Pembrolizumab, an immune checkpoint inhibitor, blocks the PD-1 pathway to enhance anti-tumor immunity.

ClinicalTrials.gov ID: NCT04701476

An Open-label Phase 1/2 Dose Finding, Safety and Efficacy Study of Oral NEO212 in Patients with Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Uncontrolled Brain Metastasis in Patients with Select Solid Tumors.

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.

No known activity

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

TrialFetch AI summary: This clinical trial evaluates the safety and efficacy of the investigational drug NEO212, a novel conjugate of temozolomide and perillyl alcohol with enhanced brain penetration, in adults with Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype, or uncontrolled brain metastases from select solid tumors, including combinations with standard treatments like pembrolizumab or ipilimumab.

ClinicalTrials.gov ID: NCT06047379

Beamion BCGC-1: A Phase Ib Dose Escalation and Phase II Dose Optimization, Randomized, Open-label, Multicenter Trial of Oral Zongertinib (BI 1810631) Alone or in Combination With Other Agents for the Treatment of Patients With Advanced HER2+ Metastatic Breast Cancer (mBC) and Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (mGEAC)

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.

TrialFetch AI summary: This trial enrolls adults with HER2-positive metastatic breast, gastric, gastroesophageal junction, or esophageal adenocarcinoma who have progressed after standard therapy, testing the selective HER2 tyrosine kinase inhibitor zongertinib (BI 1810631) alone or in combination with HER2-targeted agents (T-DXd, T-DM1, trastuzumab, capecitabine). Eligible patients must have measurable disease and good performance status (ECOG 0-1).

ClinicalTrials.gov ID: NCT06324357

A Phase 1/2 Study to Assess the Safety and Antitumor Activity of APL-5125 in Adults With Selected Advanced Solid Tumors

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.

No known activity

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

TrialFetch AI summary: Eligible patients are adults with select advanced or metastatic solid tumors (including colorectal, cholangiocarcinoma, appendiceal, pancreatic, gastric, endometrial, triple negative breast, ovarian, or prostate cancers) who have exhausted standard therapies; phase 2 focuses on colorectal cancer. Therapy is with APL-5125, an oral CK2α kinase inhibitor targeting Wnt signaling.

ClinicalTrials.gov ID: NCT06399757

Phase 1b, Multicenter, Open-Label, Dose Escalation and Dose Expansion Study of RMC-6291 in Combination with RMC-6236 in Participants with Advanced KRAS G12C Mutant Solid Tumors

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.

TrialFetch AI summary: This trial enrolls adults with advanced or metastatic solid tumors harboring KRAS G12C mutations (including pretreated NSCLC and other solid tumors), who receive a combination of the investigational KRAS G12C inhibitors RMC-6291 and RMC-6236. Both agents specifically inhibit KRAS G12C mutant protein to suppress tumor growth, and eligibility includes both KRAS G12C inhibitor–naïve and previously treated patients, excluding those with primary CNS tumors or active brain metastases.

ClinicalTrials.gov ID: NCT06128551