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New treatment option for pMMR/MSS Locally Advanced Rectal Cancer
Official title Short-course Radiotherapy Followed by Sequential Chemotherapy With or Without PD-1 Monoclonal Antibody and Bevacizumab as Total Neoadjuvant Therapy in pMMR/MSS Locally Advanced Rectal Cancer （SPARK）
ClinicalTrials.gov ID: NCT07005570
What this study is testing
- What it's testing
- Safety and efficacy of Short-Course Radiotherapy Followed by Sequential Chemotherapy with or without PD-1 Monoclonal Antibody and Bevacizumab as Total Neoadjuvant Therapy in pMMR/MSS Locally Advanced Rectal Cancer. Complete Response (CR) Rate of Short-Course Radiotherapy Followed by Sequential Chemotherapy with or without PD-1 Monoclonal Antibody and Bevacizumab as Total Neoadjuvant Therapy in pMMR/MSS Locally Advanced Rectal Cancer.
- 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
- Voluntarily signed written informed consent form.
- Age ≥18 and ≤75 years at enrollment.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Life expectancy \>2 years.
- Histologically confirmed rectal adenocarcinoma.
You likely can't join if
- Suspected metastatic lesions or locally advanced unresectable disease regardless of stage.
- History of other malignancies within 5 years prior to enrollment, except those cured by local therapy (e.g., basal/squamous cell skin cancer...
- Concurrent participation in another treatment clinical trial (observational or non-treatment studies allowed).
- Acute complications requiring emergency surgery (e.g., bowel obstruction, perforation, hemorrhage).
- Multiple primary rectal cancers.
- Prior pelvic/abdominal radiotherapy.
See the full eligibility criteria
- Voluntarily signed written informed consent form.
- Age ≥18 and ≤75 years at enrollment.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Life expectancy \>2 years.
- Histologically confirmed rectal adenocarcinoma.
- Tumor biopsy demonstrating pMMR (all four mismatch repair proteins-MSH1, MSH2, MSH6, and PMS2-positive by immunohistochemistry) or genetic testing confirming MSS (microsatellite stable).
- Clinical stage II-III rectal cancer (cT3-4NanyM0 or cTxN+M0) per AJCC 8th Edition TNM staging, assessed via high-resolution MRI ± endoscopic ultrasound/transrectal Doppler ultrasound. Tumor must be ≤12 cm from the anal...
- Pre-enrollment surgical evaluation by an attending surgeon confirming eligibility for curative-intent R0 resection.
- No prior systemic or local anti-cancer therapy for rectal cancer (radiotherapy, chemotherapy, immunotherapy, biologics, or small-molecule targeted therapy).
- Willingness to provide tumor tissue (archival or fresh biopsy) and peripheral blood samples for biomarker analysis during screening and study procedures.
- Adequate organ function.
- For women of childbearing potential (WOCBP):Negative urine or serum pregnancy test within 3 days prior to treatment (serum test required if urine result is inconclusive).Agreement to use highly effective contraception...
- The subject is willing and able to comply with scheduled visits, treatment regimens, laboratory tests, and other study requirements as outlined in the protocol.
- Suspected metastatic lesions or locally advanced unresectable disease regardless of stage.
- History of other malignancies within 5 years prior to enrollment, except those cured by local therapy (e.g., basal/squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the breast).
- Concurrent participation in another treatment clinical trial (observational or non-treatment studies allowed).
- Acute complications requiring emergency surgery (e.g., bowel obstruction, perforation, hemorrhage).
- Multiple primary rectal cancers.
- Prior pelvic/abdominal radiotherapy.
- Conditions impairing oral drug absorption (e.g., dysphagia, malabsorption syndrome).
- Prior systemic/local anti-tumor therapy for locally advanced rectal cancer (surgery, chemotherapy, radiotherapy, immunotherapy [checkpoint inhibitors/agonists, cell therapy], biologics, or targeted agents).
- Non-specific immunomodulators (e.g., interleukins, interferons) within 2 weeks or anti-tumor herbal medicines within 1 week prior to treatment.
- Active autoimmune disease requiring systemic immunosuppression (e.g., corticosteroids \>10 mg/day prednisone equivalent) within 2 years (hormone replacement allowed).
- History of non-infectious pneumonitis or interstitial lung disease requiring steroids.
- Bleeding diathesis/coagulopathy or chronic anticoagulation (e.g., CHADS2 score ≥2 for atrial fibrillation).
- Uncontrolled comorbidities (e.g., decompensated cirrhosis, nephrotic syndrome, peptic ulcers) or psychiatric disorders affecting consent/study compliance.
- Cardiac history:Myocarditis/cardiomyopathy/malignant arrhythmias.Unstable angina/CHF within 12 months.Arterial thromboembolism within 6 months (e.g., stroke, TIA).Grade ≥3 venous thromboembolism (CTCAE...
- Active inflammatory bowel disease (Crohn's/ulcerative colitis) or chronic diarrhea. 16Active severe infection requiring hospitalization/systemic antibiotics within 4 weeks (excluding HBV/HCV antivirals). 17.Major...
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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.