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rectal cancer

Total Trials
22
Recruiting Now
22
Trial Phases
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 22 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 22. 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 2 (3 trials), Phase 3 (2 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 2
3
Phase 3
2
Top Sponsors
Universitair Ziekenhuis Brussel 1 trial
Renmin Hospital of Wuhan University 1 trial
Jichao Qin 1 trial
University Hospital Tuebingen 1 trial
Seoul National University Hospital 1 trial

Recruiting Clinical Trials

NCT05916040
Recruiting
Total Neoadjuvant Treatment of Rectal Cancer by MRI-guided Radiotherapy
Enrollment
35 pts
Location
Belgium
Sponsor
Universitair Ziekenhuis Brusse...
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NCT05049317
Recruiting
Multicenter Study on Postoperative Urinary and Sexual Function During Laparoscopic Functional Total Mesorectum Excision
Enrollment
88 pts
Location
China
Sponsor
Renmin Hospital of Wuhan Unive...
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NCT04999007
Recruiting
Artificial Intelligence Assists Surgeons' Decision Making
Enrollment
616 pts
Location
China
Sponsor
Jichao Qin
View Trial →
NCT06831981
Recruiting
Hyperthermia With Chemoradiotherapy in Rectal Cancer
Enrollment
264 pts
Location
Germany
Sponsor
University Hospital Tuebingen
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NCT06222255
Recruiting
The Safety and Efficacy of Transanal Irrigation in Patients With Sleep Disturbance From Low Anterior Resection Syndrome After Rectal Cancer Surgery (TraLARS)
Enrollment
52 pts
Location
South Korea
Sponsor
Seoul National University Hosp...
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NCT07359989
Recruiting
Leucine Plus Radiochemotherapy for Neoadjuvant Treatment of Locally Advanced Rectal Cancer
Enrollment
33 pts
Location
China
Sponsor
Second Affiliated Hospital, Sc...
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NCT07292298 Phase 2
Recruiting
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
Enrollment
44 pts
Location
United States
Sponsor
University of Colorado, Denver
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NCT06519006
Recruiting
Effectiveness of Pelvic Floor Exercise to Prevent LARS (Low Anterior Resection Syndrome)
Enrollment
50 pts
Location
Slovakia
Sponsor
F. D. Roosevelt University Hos...
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NCT06366841
Recruiting
Stigma and Psychological profilE in REctal-anal caNcer pAtients
Enrollment
148 pts
Location
Italy
Sponsor
Fondazione Policlinico Univers...
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NCT06123156 Phase 3
Recruiting
Interest of Early Erectile Rehabilitation With Sildenafil After Radiotherapy and Proctectomy for Rectal Cancer
Enrollment
188 pts
Location
France
Sponsor
University Hospital, Rouen
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NCT04743102
Recruiting
Multi-points and Full-thickness Biopsy in the Diagnosis of cCR After Neoadjuvant Therapy for Rectal Cancer
Enrollment
260 pts
Location
China
Sponsor
Beijing Chao Yang Hospital
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NCT06254521 Phase 2
Recruiting
The Effects of Neoadjuvant Tislelizumab Combined With Chemotherapy in Locally Advanced MSS Rectal Cancer
Enrollment
60 pts
Location
China
Sponsor
First Affiliated Hospital of G...
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NCT06194708
Recruiting
Reasons for Non-reversal of Temporary Stomas After Surgeries of Mid-low Rectal Cancer (NORESTO Study)
Enrollment
235 pts
Location
China
Sponsor
Peking Union Medical College H...
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NCT06637462
Recruiting
A Study of Response to Standard Treatment Before Surgery in People With Rectal Cancer
Enrollment
60 pts
Location
United States
Sponsor
Memorial Sloan Kettering Cance...
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NCT04245683
Recruiting
Feasibility of Non-Operative Management of Rectal Cancer in a Rural Population
Enrollment
50 pts
Location
United States
Sponsor
Bassett Healthcare
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NCT07605611
Recruiting
Somatostatin Plus Clear Liquid Diet Versus Diverting Stoma in Patients With Rectal Cancer Undergoing Ultra-Low Anterior Resection
Enrollment
72 pts
Location
China
Sponsor
Tongji Hospital
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NCT05772481
Recruiting
Interest of PET-MRI in the Evaluation of the Response After Neoadjuvant Treatment of Locally Advanced Rectal Adenocarcinoma
Enrollment
50 pts
Location
France
Sponsor
Centre Paul Strauss
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NCT03671252 Phase 3
Recruiting
Prospectively Randomized Control Clinical Trial of FOLFOXIRI Preoperative Chemotherapy Alone on Rectal Cancer in Local Advance Comparing to Oral Capecitabine Combined With Long-term Radiation
Enrollment
776 pts
Location
China
Sponsor
Sun Yat-sen University
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NCT06633133
Recruiting
Virtual Ileostomy Versus Diverting Ileostomy in Patients Undergoing Total Mesorectal Excision
Enrollment
620 pts
Location
China
Sponsor
Daping Hospital and the Resear...
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NCT07260526
Recruiting
Response-adapted Total Neoadjuvant Therapy Guided by Induction Chemotherapy in Early- and Intermediate-risk Low Rectal Cancer for Implementation of a Watch-and-wait Strategy
Enrollment
60 pts
Location
China
Sponsor
West China Hospital
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NCT06050447
Recruiting
Factors Affecting the Results of Treatment of Patients With Colorectal Cancer
Enrollment
1,200 pts
Location
Russia
Sponsor
Immanuel Kant Baltic Federal U...
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NCT06765616 Phase 2
Recruiting
Adebrelimab Injection (PD-L1) Combined With Short Course Radiotherapy and Chemotherapy for Neoadjuvant Therapy of Locally Advanced Rectal Cancer
Enrollment
31 pts
Location
China
Sponsor
Feng Tian
View Trial →

Related Conditions

rectal adenocarcinoma (2) low anterior resection syndrome (1) insomnia (1) sleep disorder (1) prevention (1) lars low anterior resection syndrome (1) pelvic floor disorders (1) low anterior resection (1) anal cancer (1) neoadjuvant therapy (1) complete remission (1) metastasis (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: April 2026  ·  Data Methodology