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rectal cancer

Total Trials
24
Recruiting Now
24
Trial Phases
Phase 3, Phase 1, Phase 2, Phase 2, Phase 3

Cancer clinical trials represent the largest single category of recruiting studies worldwide, encompassing everything from early-phase safety studies of novel oncology drugs to large Phase 3 comparisons against current standard-of-care chemotherapy regimens. The field has accelerated dramatically with the rise of immunotherapy, targeted therapies, and CAR-T cell treatments that have transformed outcomes for previously untreatable malignancies.

Trials include checkpoint inhibitors (PD-1/PD-L1 agents), KRAS inhibitors, ADC (antibody-drug conjugates), combination chemotherapy regimens, radiation protocols, and surgical technique comparisons. Many trials stratify by biomarker status (PD-L1 expression, TMB, MSI-H) to identify patients most likely to benefit.

The NCI, pharmaceutical sponsors, and academic cancer centers collectively fund thousands of oncology trials annually across every cancer type.

Disease Burden & Epidemiology

Cancer is a leading cause of death globally, with approximately 19.3 million new cases and 10 million deaths recorded in 2020 according to the Global Cancer Observatory. In the United States alone, the American Cancer Society estimates roughly 1.9 million new cancer diagnoses annually. The lifetime risk of developing invasive cancer is approximately 40% for men and 39% for women in the US. While survival rates have improved substantially β€” the five-year survival rate across all cancers has risen from 49% in the 1970s to approximately 68% today β€” the disease remains the second leading cause of death in high-income countries. Lung, colorectal, breast, and prostate cancers collectively account for the highest incidence and mortality globally, while rare malignancies such as pancreatic and glioblastoma continue to carry the poorest prognoses. Geographic variation is substantial: low- and middle-income countries bear a disproportionate burden due to limited screening infrastructure, delayed diagnosis, and restricted access to systemic therapy. Clinical trials are essential to improving these outcomes at a population level.

Key Research Trends & Landmark Studies

The past decade has produced transformative trial results that have fundamentally changed cancer treatment standards. The KEYNOTE-024 trial established pembrolizumab as first-line standard of care for high PD-L1 non-small cell lung cancer, replacing chemotherapy in a defined biomarker population. The CheckMate 067 trial demonstrated durable 10-year survival in advanced melanoma patients receiving nivolumab plus ipilimumab combination immunotherapy. The DESTINY-Breast03 trial validated trastuzumab deruxtecan (T-DXd) as superior to standard HER2-targeted therapy in HER2-positive breast cancer, accelerating the ADC class across tumor types. In hematology, the TRANSCEND trial led to axicabtagene ciloleucel approval for relapsed DLBCL, establishing CAR-T cell therapy as standard salvage in B-cell lymphoma. The SOLO-1 trial confirmed olaparib (PARP inhibitor) benefit in BRCA-mutated ovarian cancer maintenance, validating germline testing as a standard oncology workflow. Currently active platform trials β€” including NCI-MATCH, TAPUR, and ASCO TARGET β€” use basket and umbrella designs to match patients to experimental therapies based on molecular tumor profiling rather than histological site of origin.

Patient Guide: How to Find & Join a Trial

If you or a family member has been diagnosed with cancer, discussing clinical trial eligibility with your oncologist at every treatment decision point is strongly recommended β€” not just at relapse. Academic cancer centers affiliated with the NCI Cancer Center Program (51 designated centers) typically offer the widest trial portfolio and dedicated clinical trials navigation services. To search independently, filter by your cancer type, treatment history, and location on this page or directly on ClinicalTrials.gov. When reviewing a trial, focus on the eligibility criteria section: prior treatment requirements, performance status (ECOG 0-2 is most common), biomarker requirements, and organ function thresholds are the most frequent barriers to enrollment. Ask your care team about tissue and blood banking β€” many trials require archival biopsy material for biomarker testing before enrollment. Most Phase 2 and 3 oncology trials cover experimental treatment costs; standard-of-care costs may or may not be covered by insurance.

Frequently Asked Questions — rectal cancer Clinical Trials

How many clinical trials are currently recruiting for rectal cancer?
ClinicalMetric currently tracks 24 actively recruiting clinical trials for rectal cancer, sourced in real time from ClinicalTrials.gov. The total number of registered studies—including those not yet enrolling or in active follow-up—is 24. Trial availability changes daily as new studies open enrollment and existing ones reach capacity.
What trial phases are available for rectal cancer?
rectal cancer research spans Phase 1 (2 trials), Phase 2 (5 trials), Phase 3 (4 trials). Phase 1 studies evaluate safety and dosing in small groups, Phase 2 studies assess preliminary efficacy in 100–300 participants, and Phase 3 trials compare the new treatment against the standard of care in 300–3,000+ patients. Phase 4 post-approval studies monitor long-term outcomes in real-world populations.
How do I find out if I qualify for a rectal cancer clinical trial?
Eligibility criteria for rectal cancer trials vary by study and typically specify age range, disease stage or severity, prior treatment history, and specific diagnostic or laboratory parameters. Each listing on ClinicalMetric links to the full protocol on ClinicalTrials.gov, where inclusion and exclusion criteria are documented. Contact the sponsoring site's research coordinator directly to confirm your eligibility—your treating physician or specialist can also help identify the most appropriate trial based on your medical history and current treatment status.
Trial Phases
Phase 1
2
Phase 2
5
Phase 3
4
Top Sponsors
Second Affiliated Hospital, Zhejiang University, School of Medicine 2 trials
Sunnybrook Health Sciences Centre 1 trial
Shandong Cancer Hospital and Institute 1 trial
Skane University Hospital 1 trial
Sixth Affiliated Hospital, Sun Yat-sen University 1 trial

Recruiting Clinical Trials

NCT03908684
Recruiting
Ultrasound Spectroscopy as Early Indicators of Radiation Treatment Response in Prostate, Rectum and Head & Neck Cancers
Enrollment
320 pts
Location
Canada
Sponsor
Sunnybrook Health Sciences Cen...
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NCT07595107
Recruiting
Concordance Between Large Language Model and Multidisciplinary Team Recommendations in Rectal Cancer
Enrollment
180 pts
Location
China
Sponsor
Shandong Cancer Hospital and I...
View Trial →
NCT06214988
Recruiting
Selective Defunctioning Stoma in Low Anterior Resection for Rectal Cancer
Enrollment
212 pts
Location
Sweden
Sponsor
Skane University Hospital
View Trial →
NCT05523245
Recruiting
Predicting the Efficacy of Neoadjuvant Therapy in Patients With Locally Advanced Rectal Cancer Using an AI Platform Based on Multi-parametric MRI
Enrollment
1,700 pts
Location
China
Sponsor
Sixth Affiliated Hospital, Sun...
View Trial →
NCT04087421 Phase 3
Recruiting
Comparison of Transanal Irrigation and Glycerol Suppositories in Treatment of Low Anterior Resection Syndrome
Enrollment
114 pts
Location
Denmark
Sponsor
University of Aarhus
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NCT02579278
Recruiting
Circulating Tumour DNA (ctDNA) in Patients With Colorectal Cancer and the Relationship to Imaging Features of Extramural Venous Invasion
Enrollment
100 pts
Location
United Kingdom
Sponsor
Imperial College London
View Trial →
NCT07359989
Recruiting
Leucine Plus Radiochemotherapy for Neoadjuvant Treatment of Locally Advanced Rectal Cancer
Enrollment
33 pts
Location
China
Sponsor
Second Affiliated Hospital, Zh...
View Trial →
NCT05938322
Recruiting
Ketogenic Diet Compliance in Patients Undergoing Radiotherapy for Pelvic Cancers
Enrollment
194 pts
Location
Italy
Sponsor
Fondazione Policlinico Univers...
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NCT07566559
Recruiting
Rectal Cancer Neoadjuvant Therapy-Real World Study
Enrollment
869 pts
Location
China
Sponsor
Beijing Friendship Hospital
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NCT05868226 Phase 1, Phase 2
Recruiting
PRE-ISPY Phase I/II Oncology Platform Program
Enrollment
280 pts
Location
United States
Sponsor
QuantumLeap Healthcare Collabo...
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NCT06923150
Recruiting
A Randomised Clinical Investigation to Assess Efficacy of Low Volume Transanal Irrigation by Qufora® IrriSedo MiniGo Versus Conservative Treatment for Low Anterior Resection Syndrome Patients
Enrollment
78 pts
Location
France
Sponsor
Qufora A/S
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NCT06589388
Recruiting
ctDNA Monitoring to Predict the Efficacy of TNT for Rectal Cancer
Enrollment
100 pts
Location
Vietnam
Sponsor
Gene Solutions
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NCT06536127
Recruiting
Prospective Monocentric Study Evaluating the Circulating NK Cells Phenotype and the ImmunoScore® in Patients With Non Metastatic Rectal Cancer
Enrollment
100 pts
Location
France
Sponsor
Institut Sainte Catherine
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NCT04075305
Recruiting
The MOMENTUM Study: The Multiple Outcome Evaluation of Radiation Therapy Using the MR-Linac Study
Enrollment
8,000 pts
Location
United States, Austr...
Sponsor
UMC Utrecht
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NCT07098182
Recruiting
Contribution of Preserving the Superior Left Colic Artery to the Vascularization of the Descending Colon Prior to Colorectal Anastomosis During Left-Sided or Rectal Resections for Colorectal or Ovarian Cancer. (Revascularisation Colique)
Enrollment
50 pts
Location
France
Sponsor
Institut du Cancer de Montpell...
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NCT07070622 Phase 3
Recruiting
Planed Organ Preservation for Low Rectal Cancer After Neoadjuvant Chemotherapy (OPLAR)
Enrollment
186 pts
Location
China
Sponsor
West China Hospital
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NCT06758830 Phase 2, Phase 3
Recruiting
Total Neoadjuvant Therapy and Organ Preservation Versus Surgery for Rectal Cancer.
Enrollment
400 pts
Location
Lithuania
Sponsor
National Cancer Center Affilia...
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NCT05772923
Recruiting
Organ Preservation in Rectal Cancer: Contact X-ray Brachytherapy vs Extending the Waiting Interval and Local Excision
Enrollment
168 pts
Location
Netherlands
Sponsor
The Netherlands Cancer Institu...
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NCT06126406 Phase 1
Recruiting
Clinical Study of CEA Targeting Chimeric Antigen Receptor T Lymphocytes(CAR-T) for CEA Positive Advanced Malignant Solid Tumors
Enrollment
60 pts
Location
China
Sponsor
Chongqing Precision Biotech Co...
View Trial →
NCT05672524 Phase 2
Recruiting
A Study of Tucatinib and Trastuzumab in People With Rectal Cancer
Enrollment
37 pts
Location
United States
Sponsor
Memorial Sloan Kettering Cance...
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NCT05566249
Recruiting
A Study to Validate the Safety and Feasibility of ArtiSential in Colorectal Cancer Surgery Using Prospectively Constructed Multi-center Registry
Enrollment
1,000 pts
Location
South Korea
Sponsor
Samsung Medical Center
View Trial →
NCT05563922 Phase 2
Recruiting
Organ Preservation Strategy of Total Neoadjuvant Chemoradiotherapy for Low Rectal Carcinoma
Enrollment
56 pts
Location
China
Sponsor
Shanghai Zhongshan Hospital
View Trial →
NCT06770270 Phase 2
Recruiting
Pucotenlimab Plus Radiotherapy and Chemotherapy for Neoadjuvant Treatment of Locally Advanced Rectal Cance(PUCRT)
Enrollment
68 pts
Location
China
Sponsor
Second Affiliated Hospital, Zh...
View Trial →
NCT07132463 Phase 3
Recruiting
Neoadjuvant Chemoradiotherapy Followed by Chemotherapy With or Without Tislelizumab for Resectable Ultra-low Rectal Cancer: The RELIEVE-02 Study
Enrollment
196 pts
Location
China
Sponsor
Fudan University
View Trial →

Related Conditions

colon cancer (3) quality of life (3) prostate cancer (2) head and neck cancer (2) low anterior resection syndrome (2) rectal neoplasms (2) breast cancer (2) lung cancer (2) esophagus cancer (2) organ preservation (2) cancer (1) her2 positive breast cancer (1)
ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional. Full Disclaimer  ·  Last Reviewed: November 2026  ·  Data Methodology