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rectal cancer

Total Trials
22
Recruiting Now
22
Trial Phases
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 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 1 (1 trial), Phase 2 (2 trials), Phase 3 (1 trial). 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
1
Phase 2
2
Phase 3
1
Top Sponsors
Imperial College London 2 trials
QuantumLeap Healthcare Collaborative 1 trial
Universitair Ziekenhuis Brussel 1 trial
Institute of Oncology Ljubljana 1 trial
Peking University Cancer Hospital & Institute 1 trial

Recruiting Clinical Trials

NCT05868226 Phase 1, Phase 2
Recruiting
PRE-ISPY Phase I/II Oncology Platform Program
Enrollment
280 pts
Location
United States
Sponsor
QuantumLeap Healthcare Collabo...
View Trial →
NCT05916040
Recruiting
Total Neoadjuvant Treatment of Rectal Cancer by MRI-guided Radiotherapy
Enrollment
35 pts
Location
Belgium
Sponsor
Universitair Ziekenhuis Brusse...
View Trial →
NCT07427901
Recruiting
Quality Of Life In Colorectal Cancer Survivors
Enrollment
368 pts
Location
Slovenia
Sponsor
Institute of Oncology Ljubljan...
View Trial →
NCT06209099
Recruiting
Organ Preservation First Strategy and Intentional Watch and Wait for MRI Defined Low-risk Rectal Cancer
Enrollment
96 pts
Location
China
Sponsor
Peking University Cancer Hospi...
View Trial →
NCT03466424
Recruiting
Short-course Radiotherapy (5×6Gy/7Gy/8Gy) Followed by Neo-adjuvant Chemotherapy for Locally Advanced Rectal Cancer
Enrollment
9 pts
Location
China
Sponsor
Fujian Medical University Unio...
View Trial →
NCT04525989
Recruiting
Preoperative Short-Course Radiation Therapy With PROtons Compared to Photons In High-Risk RECTal Cancer (PRORECT)
Enrollment
254 pts
Location
Sweden
Sponsor
Alexander Valdman
View Trial →
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
View Trial →
NCT04103372
Recruiting
Pre-therapeutic MRI Assessment of Early-Stage Rectal Cancer and Significant Rectal Polyps to Avoid Major Resectional Surgery
Enrollment
200 pts
Location
United Kingdom
Sponsor
Imperial College London
View Trial →
NCT04527861
Recruiting
Oncologic Outcomes of Single-incision Versus Conventional Laparoscopic Surgery for Colorectal Cancer
Enrollment
710 pts
Location
China
Sponsor
Ruijin Hospital
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NCT03731130
Recruiting
Prospective Observational Trial to Evaluate Quality of Life After Neoadjuvant Radiation or Chemoradiation Followed by Surgery in Patients With Rectal Cancer
Enrollment
100 pts
Location
Germany
Sponsor
Ludwig-Maximilians - Universit...
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NCT06314646
Recruiting
Transanal Transection and Single-stapled Anastomosis (TTSS) in Rectal Cancer Patients
Enrollment
472 pts
Location
Italy
Sponsor
Istituto Clinico Humanitas
View Trial →
NCT02704520
Recruiting
Magnetic Resonance Tumour Regression Grade (mrTRG) as a Novel Biomarker - Phase III Non CTIMP Trial
Enrollment
441 pts
Location
United Kingdom
Sponsor
Imperial College London
View Trial →
NCT04103567
Recruiting
Determination of Microbiological Factors Associated With Poor Response to Neoadjuvant Treatment in Rectal Cancers
Enrollment
220 pts
Location
France
Sponsor
Institut du Cancer de Montpell...
View Trial →
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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NCT03853733
Recruiting
Hypofractionated Palliative Radiotherapy in Patients With Advanced Non-operable Rectal Cancer
Enrollment
50 pts
Location
Spain
Sponsor
Consorci Sanitari de Terrassa
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NCT05316103
Recruiting
Targeted Optical Biopsy for Local Rectal Scars in Rectal Cancer Patients After Neoadjuvant Chemoradiotherapy
Enrollment
68 pts
Location
China
Sponsor
Nanfang Hospital, Southern Med...
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 →
NCT05434026
Recruiting
Chinese Colorectal Cancer Database
Enrollment
200,000 pts
Location
China
Sponsor
Beijing Friendship Hospital
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NCT06719414
Recruiting
Application of Amide Proton Transfer-Weighted Imaging in Predicting Pathological Complete Response After Neoadjuvant Therapy of Rectal Cancer
Enrollment
320 pts
Location
China
Sponsor
Sixth Affiliated Hospital, Sun...
View Trial →
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
View Trial →
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
View Trial →
NCT07381322
Recruiting
A Study on the Accurate Evaluation of Pseudoprogression of Rectal Cancer Immunotherapy Based on Multitemporal and Multiparameter MRI
Enrollment
300 pts
Location
China
Sponsor
Peiyi Xie
View Trial →

Related Conditions

colon cancer (3) colo rectal cancer (2) rectal neoplasms (2) colorectal cancer (2) prostate cancer (2) quality of life (2) head and neck cancer (2) her2 positive breast cancer (1) metastatic cancer (1) metastatic breast cancer (1) metastatic (1) her2 positive metastatic 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: September 2026  ·  Data Methodology