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New treatment option for Unresectable Locally Recurrent Rectal Cancer
Official title SBRT + PD-1 Antibody in Unresectable Locally Recurrent Rectal Cancer（SPARKLE）
ClinicalTrials.gov ID: NCT06767007
What this study is testing
What is PD1?
PD1 is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for unresectable locally recurrent rectal cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a prospective study to delve into the therapeutic benefits of combining stereotactic body radiation therapy (SBRT) with PD-1 monoclonal antibody treatment for patients with unresectable locally recurrent rectal cancer (ULRRC). Our aim is to ascertain the safety of this approach and to offer robust, evidence-based medical guidance for the management of ULRRC using this innovative combination therapy.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Before implementing procedures related to the research protocol rather than routine care, informed consent forms with the subject's voluntary...
- Patients with pMMR/MSS colorectal cancer;
- Age between 18 and 75 years;
- Tumor recurrence confirmed by histology, cytology, or imaging, and the multidisciplinary team (MDT) including surgeons assesses that the recurrent...
- Locally recurrent rectal adenocarcinoma without clear distant metastasis at diagnosis/MDT team assesses oligometastases as resectable/controllable...
You likely can't join if
- Patients with a history of severe drug allergies (including allergies to platinum-based agents, 5-FU, LV, and 5-HT3 receptor antagonists);
- Patients who have participated in or are currently participating in other clinical trials within 4 weeks of enrollment;
- History of receiving anti-PD-1, PD-L1, PD-L2, CTLA-4, or any other specific T-cell co-stimulation or checkpoint pathway targeted therapies;
- Severe electrolyte abnormalities;
- Presence of gastrointestinal diseases, such as active ulcers of the stomach or duodenum, ulcerative colitis, or unresected tumors with active...
- History of arterial thrombosis or deep vein thrombosis within 6 months; history of bleeding or evidence of bleeding tendency within 2 months;
See the full eligibility criteria
Who can join
- Before implementing procedures related to the research protocol rather than routine care, informed consent forms with the subject's voluntary signature and dated must be obtained in accordance with regulations and...
- Patients with pMMR/MSS colorectal cancer;
- Age between 18 and 75 years;
- Tumor recurrence confirmed by histology, cytology, or imaging, and the multidisciplinary team (MDT) including surgeons assesses that the recurrent lesion cannot achieve a one-stage R0 resection (unresectable is defined...
- Locally recurrent rectal adenocarcinoma without clear distant metastasis at diagnosis/MDT team assesses oligometastases as resectable/controllable (UICC 8th edition);
- No prior radiotherapy, or a gap of more than 6 months between the completion of initial radiotherapy and the start of retreatment, with a previous radiotherapy dose of less than 50.4Gy, and no late toxicity in the small...
- ECOG performance status 0-1;
- Peripheral blood counts and liver and kidney functions within the following allowed ranges (tested within 15 days before treatment start):
- White blood cells (WBC) ≥ 3.0×10\^9/L or Absolute Neutrophil Count (ANC) ≥ 1.5×10\^9/L;
- Hemoglobin (HGB) ≥ 80 g/L;
- Platelets (PLT) ≥ 100×10\^9/L;
- Liver transaminases (AST/ALT) \< 3.0 times the upper limit of the normal range;
- Total bilirubin (TBIL) \< 1.5 times the upper limit of the normal range;
- Creatinine (CREAT) \< 1.5 times the upper limit of the normal range;
- No history of other malignancies, not pregnant or breastfeeding, and should use effective contraception during the study period and for 6 months after the last administration;
- Expected survival ≥ 12 months.
What rules you out
- Patients with a history of severe drug allergies (including allergies to platinum-based agents, 5-FU, LV, and 5-HT3 receptor antagonists);
- Patients who have participated in or are currently participating in other clinical trials within 4 weeks of enrollment;
- History of receiving anti-PD-1, PD-L1, PD-L2, CTLA-4, or any other specific T-cell co-stimulation or checkpoint pathway targeted therapies;
- Severe electrolyte abnormalities;
- Presence of gastrointestinal diseases, such as active ulcers of the stomach or duodenum, ulcerative colitis, or unresected tumors with active bleeding; or other conditions that may lead to gastrointestinal bleeding or...
- History of arterial thrombosis or deep vein thrombosis within 6 months; history of bleeding or evidence of bleeding tendency within 2 months;
- Pregnant or breastfeeding women or women who may become pregnant with a positive pregnancy test before the first dose; or female participants who are unwilling to strictly use contraception during the study period and...
- Brain metastases with a diameter greater than 3cm or a total volume greater than 30cc;
- Clinical or radiological evidence of spinal cord compression, or tumors within 3 millimeters of the spinal cord on MRI;
- History or concurrent presence of other active malignant tumors (except for malignant tumors that have been treated curatively and have not recurred for more than 3 years or carcinoma in situ that can be cured with...
- Combined with severe electrocardiogram abnormalities or active coronary artery disease within 12 months before participating in the study, severe/unstable angina or newly diagnosed angina or myocardial infarction, New...
- Patients with active infections (infections causing fever above 38°C);
- Patients with poorly controlled hypercalcemia, hypertension, diabetes;
- Patients with severe pulmonary diseases (interstitial pneumonia, pulmonary fibrosis, severe emphysema, etc.);
- Patients with mental disorders affecting clinical treatment or a history of central nervous system diseases;
- Patients with severe complications (intestinal obstruction, renal insufficiency, liver dysfunction, cerebrovascular disorders, etc.);
- Any toxicity of grade 2 or above from previous treatments that has not yet resolved (except for anemia, alopecia, and skin pigmentation);
- Any medical condition that is unstable or would affect patient safety and compliance with the study;
- Patients deemed unsuitable for participation in this clinical trial by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.