Back to search results

DCSZ11 with Radiation and Chemotherapy for Rectal Cancer

This study is testing a new combination treatment for locally advanced rectal cancer that is mismatch repair proficient (pMMR). You would receive a drug called DCSZ11, along with a short course of radiation and chemotherapy drugs called Capecitabine and Oxaliplatin. Researchers want to see how safe this combination is and how well it works to shrink tumors before surgery. The study aims to enroll 30 participants who are at least 18 years old and have been diagnosed with this specific type of rectal cancer. Success will be measured by how many participants have a complete response to the treatment after 24 months, and by tracking any drug-related side effects that lead to stopping treatment over 12 months. The study status is currently unclear.

Study design
This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 30 participants.
What's involved
You would receive DCSZ11 intravenously (IV) for 6 cycles, radiation for 5 days, and Capecitabine and Oxaliplatin for 6 cycles. Each cycle lasts 21 days.
Compensation
Not stated in the trial record.
Follow-up
The study will measure how well the treatment works after 24 months and track drug-related side effects for 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07580339

Combining DCSZ11 With Radiation and Chemotherapy as Neoadjuvant Treatment for pMMR Locally Advanced Rectal Cancer

Not Yet Recruiting
PHASE2Ages 18+InterventionalTreatment
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
~30 participants
Updated 2026-07-28 on ClinicalTrials.gov
What's tested:DCSZ11RadiationCapecitabineOxaliplatin

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Composite Complete Response (compCR) Rate
Measured over 24 months
+1 more outcome measured

Conditions

Rectal Cancer

Explore related trials

Rectal CarcinomaMRC1 wt AlleleMSI1 Gene

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Eric Christenson, MD · PRINCIPAL_INVESTIGATOR · Sidney Kimmel Comprehensive Cancer Center Johns Hopkins Medical Institution

Who to contact

Colleen Apostal, RN
[email protected]
410-614-3644
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Age ≥18 years.
Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1.
Rectal cancer (with tumor tissue present at or below the peritoneal reflection) as determined by MRI pelvis or endoscopic ultrasound.
Have histologically proven mismatch repair proficient (pMMR) or microsatellite stable (MSS) rectal adenocarcinoma.
Must not have received any prior systemic treatment or radiation.
Patients have the following clinical staging:
cT4 any node status
Any T stage cN2 node status
Any T or N status, evidence of suspicious lateral lymph nodes \> 10 mm in size in short axis
Evidence of extramural vascular invasion on MRI pelvis
Absence of distant metastases on CT or MRI imaging
Patients must have adequate organ and marrow function defined by study-specified laboratory tests and procedures.
Left ventricular ejection fraction (LVEF) assessment with documented LVEF ≥ 50% by either TTE or Multigated Acquisition (MUGA) (TTE preferred) within 6 months from first study drug administration.
For both Women and Men, must use acceptable form of birth control while on study.
Ability to understand and willingness to sign a written informed consent document.

Exclusion

Have received an investigational agent or used an investigational device within 28 days of the first dose of study drug.
Have expected to require any other form of systemic or localized antineoplastic therapy while on study.
Have had surgery within 28 days of dosing of investigational agent, excluding minor procedures (dental work, skin biopsy, etc.).
History of severe hypersensitivity reaction to any monoclonal antibody.
History of encephalitis, meningitis, dementia, Parkinson's or uncontrolled seizures within 1 year prior to the first dose of study drug.
Uncontrolled infection of HIV, hepatitis B virus (HBV), hepatitis C virus (HCV), or Tuberculosis.
Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, metastatic cancer, or psychiatric illness/social situations that would limit compliance with study requirements.
Any tissue or organ allograft, regardless of need for immunosuppression, including corneal allograft.
Patient has a pulse oximetry of \<92% on room air.
Patient is on supplemental home oxygen.
Has clinically significant heart disease.
Conditions, including alcohol or drug dependence that would affect the patient's ability to comply with study visits and procedures.
Patient is pregnant or breastfeeding.
Unwilling or unable to follow the study schedule for any reason.
Patient received a live vaccine within 30 days of planned start of study medication.
Receipt of COVID-19 vaccination within 1 week of planned start of study medication or for which the planned COVID-19 vaccinations would not be completed 1 week prior to start of study medication.

What this trial measures

  • Composite Complete Response (compCR) Rate24 months

    compCR is defined as the proportion of subjects with a pathologic complete response at the time of surgical resection or complete clinical response. Pathologic complete response is defined as subjects with no viable tumor cell noted on pathological evaluation of the resection specimen using the College of American Pathologists (CAP) tumor regression scoring system (CAP tumor regression score of 0). Complete clinical response is defined as subjects with an absence of tumor on endoscopy and no evidence of metastatic disease or recurrence on imaging for 1 year from the end of treatment.

  • Number of participants experiencing a drug-related toxicity requiring treatment discontinuation12 months

    Defined using NCI CTCAE v6.0