New combo aims to beat rectal cancer without surgery
NCT ID NCT07527026
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding the immunotherapy drug camrelizumab to standard chemoradiotherapy can make rectal tumors disappear completely in people with a common type of locally advanced rectal cancer. About 44 adults aged 18-75 with tumors within 10 cm of the anus will receive the combination before any surgery. The goal is to see if more patients can avoid permanent colostomy and keep their rectum.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 44 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Feb 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion 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 limit of normal (ULN); serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5× ULN; serum creatinine ≤1.5× ULN or creatinine clearance ≥50 mL/min; international normalized ratio (INR) ≤1.5× ULN; activated partial thromboplastin time (APTT) ≤1.5× ULN; Fertile male or female patients willing to use contraceptive measures during the trial. Exclusion Criteria: * 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 significant supraventricular or ventricular arrhythmias that have not been clinically intervened or remain poorly controlled after intervention. 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 active pulmonary inflammation; presence of signs or symptoms of infection within 14 days prior to the first dose of study drug, or requiring oral or intravenous antibiotic therapy (excluding prophylactic antibiotic use). Presence of any active autoimmune disease or history of autoimmune disease (e.g., interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism \[excluding patients with stable hormone levels after treatment\]; patients with childhood asthma that has completely resolved and requires no intervention in adulthood, or vitiligo, may be included; subjects requiring bronchodilators for medical intervention are not eligible). 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 with hepatitis B and C. 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 prednisone or equivalent physiological dose of other corticosteroids). 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 carcinoma of the skin, squamous cell carcinoma of the skin, or cervical carcinoma in situ, which may be considered for enrollment. 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, family or social factors, or factors that may affect subject safety or compliance.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Chinese PLA General Hospital
RECRUITINGBeijing, Beijing Municipality, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can drug cocktail spare rectal cancer patients from surgery?
- Can two immunotherapy drugs help rectal cancer patients skip pelvic radiation?
- Can a Butter-Derived supplement protect the gut during cancer radiation?
- Can an immunotherapy cocktail make rectal tumors disappear before surgery?
- MRI and microbes: a new way to predict rectal cancer outcomes?