Updated June 2026 · ClinicalTrials.gov
Phase 3 Colorectal Cancer Trials
11 Phase 3 trials for Colorectal Cancer, the final stage before a treatment can be submitted for FDA approval.
11 Phase 3 clinical trials for Colorectal Cancer are registered on ClinicalTrials.gov. Phase 3 is the final stage of testing before a treatment can be submitted for FDA approval, and the trials below come directly from the federal registry. Always talk to your doctor before contacting a study site.
What Phase 3 Means for Colorectal Cancer
Phase 3 trials are the largest and most expensive stage of clinical research before potential FDA approval. For Colorectal Cancer, a Phase 3 protocol typically enrolls several hundred to several thousand patients across many medical centers, randomizes participants between the investigational treatment and either a placebo or current standard of care (where ethically appropriate), and tracks them for months or years to confirm that the treatment is both effective and safe in a real-world patient population.
11 Phase 3 trials for Colorectal Cancer are currently registered. Conditions in this range often have a focused research agenda with a small number of late-stage candidates, frequently targeting a specific subpopulation or stage of the disease.
The Netherlands Cancer Institute (1), Fudan University (1), Yanhong Deng (1) lead the Phase 3 Colorectal Cancer sponsor list. The blend of industry, academic, and government sponsors on a condition's Phase 3 list is a useful signal of how broadly the research community is engaged with the disease.
Phase 3 Colorectal Cancer Trials on ClinicalTrials.gov
Induction Treatment for Initially Unresectable Colorectal Liver Metastases: Combined Hepatic Arterial Infusion Pump...
The goal of this randomized clinical trial is to investigate induction treatment with Hepatic Arterial Infusion Pump therapy combined with systemic therapy (HAIP-SYST) in...
Neoadjuvant FOLFOXIRI Versus CapeOX Chemotherapy for Local Advanced Rectal Cancer
This is a phase III randomized controlled trial comparing the efficacy and safety of FOLFOXIRI versus CapeOX as neoadjuvant regimen in treating patients with middle and upper...
Neoadjuvant mFOLFOXIRI Plus Bevacizumab in Patients With High-Risk Locally Advanced Rectal Cancer
Multimodality treatment that comprises preoperative fluoropyrimidine with concurrent radiotherapy followed by total mesorectal excision (TME) surgery and adjuvant...
Total Neoadjuvant Treatment ±Immunotherapy for High Risk Locally Advanced Rectal Cancer (TNTi)
The goal of this clinical trial is to compare the PCR rate between Total Neoadjuvant Treatment ±Immunotherapy in high risk locally advanced rectal cancer. The main questions it...
NALIRIFOX Plus Targeted Therapy Versus FOLFOX Plus Targeted Therapy as First-line Treatment for Metastatic Colorectal...
To explore the safety and efficacy of NALIRIFOX plus targeted therapy versus FOLFOX plus targeted therapy as first-line treatment for metastatic colorectal cancer.
Botensilimab + Balstilimab vs Best Supportive Care as Therapy in Chemo-refractory, Unresectable, Colorectal...
This study is being done to answer the main question of: Do patients with colorectal cancer that cannot be removed by surgery, that is treated with two new immunotherapy drugs,...
Stereotactic Ablative Radiotherapy (SABR) for the Treatment of Patients With Metastatic Cancer, ID-COMET Trial
This protocol is comprised of three unblinded, randomized, single-center studies to evaluate the impact of immediate versus three-month delayed comprehensive ablative treatment on...
DEBIRI Plus Chemotherapy vs. Chemotherapy Alone in Colorectal Cancer Liver Metastases
A total of 116 patients who meet the inclusion criteria and are chemotherapy-naïve for their metastatic disease, will be randomly assigned to either the treatment group (DEBIRI...
A Phase Ib/III Study of Suvemcitug Plus FTD/TPI in Participants With Refractory Metastatic Colorectal Cancer
The primary goal of Phase Ib Study is to evaluate the safety of Suvemcitug in combination with trifluridine/tipiracil tablets in colorectal cancer participants. The primary goal...
Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer
The primary purpose of this study is to evaluate the efficacy of perioperative dostarlimab compared with standard of care (SOC) in participants with untreated T4N0 or Stage III...
Mebendazole as Adjuvant Treatment for Colon Cancer
mebendazole treating colon cancer
What Participation Looks Like
Phase 3 trials for Colorectal Cancer typically enroll several hundred to several thousand participants across multiple sites. Participation involves a screening visit to confirm eligibility, randomization to either the investigational treatment or a comparator (often the current standard of care), regular study visits over months or years, and follow-up after the active treatment period. The protocols, time commitments, and visit schedules differ from trial to trial — read the per-trial page for the specifics before discussing participation with your doctor.
Each trial begins with informed consent and a screening visit, where the study team confirms eligibility against the inclusion and exclusion criteria. Randomization assigns participants to either the investigational treatment or a comparator. Standard-of-care portions of the protocol are typically billed to insurance; trial-specific procedures (extra imaging, biopsies, lab draws beyond standard care) are usually covered by the sponsor. Read each trial\'s detailed page for its specific time commitment and visit schedule.
Authoritative Resources for Colorectal Cancer Trials
Verify any individual trial directly on ClinicalTrials.gov. For the federal context on how Phase 3 results feed into approval decisions, see the FDA drug approval process. For oncology-specific trial resources, the National Cancer Institute publishes patient-oriented overviews. For trials registered outside the U.S., the WHO ICTRP aggregates registries from around the world.
Frequently Asked Questions
What is a Phase 3 Colorectal Cancer trial?
A Phase 3 trial is the final stage of clinical testing before a treatment can be submitted to the FDA for approval. For Colorectal Cancer, Phase 3 studies typically enroll hundreds to thousands of patients across multiple medical centers, comparing the new treatment to the current standard of care or a placebo (where ethically appropriate). The goal is to confirm efficacy, monitor side effects in a larger population, and generate the evidence the FDA needs to make an approval decision.
How many Phase 3 Colorectal Cancer trials are recruiting?
11 Phase 3 trials for Colorectal Cancer are currently registered on ClinicalTrials.gov. Recruitment status varies by trial — some are actively enrolling, some have closed enrollment but are still in the active treatment phase, and some are completing follow-up. Click any trial below to see its current status, eligibility criteria, and contact information.
Who can participate in a Phase 3 Colorectal Cancer trial?
Phase 3 eligibility depends entirely on the specific trial protocol. Each trial sets its own inclusion criteria (typically a confirmed diagnosis, certain disease stage or severity, age range) and exclusion criteria (often previous treatments, comorbidities, lab values that fall outside set ranges). The trial pages on this site translate the clinical eligibility criteria into plain English alongside the original text. Whether you fit any specific trial is a medical decision your doctor needs to confirm.
Is participating in a Phase 3 Colorectal Cancer trial safe?
Phase 3 trials use treatments that have already passed Phase 1 (safety in small groups) and Phase 2 (initial efficacy and side-effect monitoring), so the safety profile is better understood than in earlier-phase studies. That said, side effects can still emerge in larger populations, and the trial protocol may require additional procedures (lab draws, imaging, biopsies) beyond standard care. The informed consent document for any specific trial details the known risks. Discuss those risks with your physician before deciding whether to participate.
Where does this trial data come from?
All trial data is sourced from the ClinicalTrials.gov API v2, the federal registry maintained by the National Library of Medicine at NIH. Under FDAAA 801, most U.S. drug and device trials must register on ClinicalTrials.gov, making it the most comprehensive source of trial information. Sponsors are required to update trial status within 30 days of a change, but delays occur — always confirm the current status with the trial site before traveling for screening.
How This Page Is Built
The trial list is filtered to ClinicalTrials.gov registrations whose phase field includes Phase 3 and whose condition list includes Colorectal Cancer. Trial counts and the sponsor leaderboard are computed from the same record set. Plain-English eligibility translations on each linked trial page preserve the original clinical text alongside the accessible version. Read the full methodology for the data pipeline and known limitations.
Phase 3 Trials for Other Conditions
Source: ClinicalTrials.gov API v2, maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData, Phase 3 Colorectal Cancer list, June 2026. Data: ClinicalTrials.gov."
Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.
Last updated 2026-06-26 · 11 Phase 3 trials tracked for Colorectal Cancer.