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New treatment option for Locally Advanced Rectal Cancer
Official title A Single-arm Phase II Clinical Study of Camrelizumab Combined With Long-course Chemoradiotherapy for Total Neoadjuvant Therapy in Locally Advanced Low pMMR/MSS Rectal Cancer
ClinicalTrials.gov ID: NCT07527026
What this study is testing
What is Camrelizumab?
Camrelizumab is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for locally advanced 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
- In pMMR/MSS locally advanced rectal cancer, can the innovative "chemo-immunotherapy induction + LCRT + chemo-immunotherapy consolidation" approach significantly improve the complete response rate and create opportunities for organ preservation?
- 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
- Aged 18-75 years, male or female;
- Histologically confirmed T3-4 and/or N+ rectal adenocarcinoma (AJCC/UICC TNM staging, 8th edition);
- Lower margin of the tumor ≤10 cm from the anal verge;
- Expected to achieve R0 resection;
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
You likely can't join if
- Prior or current receipt of any anti-tumor therapy for cancer, including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.
- Known genetic testing showing MSI-H (microsatellite instability-high) or immunohistochemistry showing dMMR (deficient mismatch repair).
- Major surgery or severe trauma within 4 weeks prior to the first dose of study drug.
- Known allergy, hypersensitivity, or contraindication to any component of camrelizumab or platinum-based agents.
- Presence of poorly controlled cardiac clinical symptoms or diseases, including but not limited to: (1) heart failure ≥ NYHA class II; (2) unstable...
- Severe infection (CTCAE grade \>2) within 4 weeks prior to the first dose of study drug, such as severe pneumonia requiring hospitalization...
See the full eligibility criteria
- Aged 18-75 years, male or female;
- Histologically confirmed T3-4 and/or N+ rectal adenocarcinoma (AJCC/UICC TNM staging, 8th edition);
- Lower margin of the tumor ≤10 cm from the anal verge;
- Expected to achieve R0 resection;
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
- Able to swallow tablets normally;
- No prior anti-tumor therapy for rectal cancer, including radiotherapy, chemotherapy, surgery, etc.;
- Planned to undergo surgical treatment after neoadjuvant therapy;
- No contraindications to surgery;
- Laboratory tests must meet the following requirements: white blood cell count (WBC) ≥4×10⁹/L; absolute neutrophil count (ANC) ≥1.5×10⁹/L; platelet count ≥100×10⁹/L; hemoglobin ≥90 g/L; serum total bilirubin ≤1.5× upper...
- Fertile male or female patients willing to use contraceptive measures during the trial.
- Prior or current receipt of any anti-tumor therapy for cancer, including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.
- Known genetic testing showing MSI-H (microsatellite instability-high) or immunohistochemistry showing dMMR (deficient mismatch repair).
- Major surgery or severe trauma within 4 weeks prior to the first dose of study drug.
- Known allergy, hypersensitivity, or contraindication to any component of camrelizumab or platinum-based agents.
- Presence of poorly controlled cardiac clinical symptoms or diseases, including but not limited to: (1) heart failure ≥ NYHA class II; (2) unstable angina; (3) myocardial infarction within 1 year; (4) clinically...
- Severe infection (CTCAE grade \>2) within 4 weeks prior to the first dose of study drug, such as severe pneumonia requiring hospitalization, bacteremia, infectious complications, etc.; baseline chest imaging indicating...
- Presence of any active autoimmune disease or history of autoimmune disease (e.g., interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism...
- Congenital or acquired immunodeficiency, such as HIV infection, active hepatitis B (HBV DNA ≥500 IU/mL), hepatitis C (positive HCV antibody with HCV-RNA above the lower limit of detection of the assay), or co-infection...
- Use of immunosuppressive drugs within 14 days prior to the first dose of study drug, excluding nasal and inhaled corticosteroids or physiological doses of systemic corticosteroids (i.e., no more than 10 mg/day...
- Known interstitial lung disease, except for interstitial changes detected only on imaging.
- Diagnosis of another malignancy within 5 years prior to the first dose of study drug, except for malignancies with a low risk of metastasis or death (5-year survival rate \>90%), such as adequately treated basal cell...
- Pregnant or breastfeeding women.
- Any other factors deemed by the investigator that may lead to premature termination of the study, such as other serious diseases (including psychiatric disorders) requiring concomitant treatment, alcoholism, drug abuse...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, 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 Beijing, Beijing Municipality, 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.