Locally Advanced Rectal CancerPhase 2NCT07527026
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
A Phase 2 study testing Camrelizumab in people with Locally Advanced Rectal Cancer, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
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? Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Rectal Cancer
- What is being tested?
- Camrelizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2026to 1 Feb 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality
Guanghai Dai, MD, +86 13801232381
About this study
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?
- Conditions
- Locally Advanced Rectal Cancer
- Being tested
- Camrelizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CamrelizumabDrug
patients first receive 2 cycles of camrelizumab combined with CAPOX (capecitabine 1000 mg/m² orally twice daily on days 1-14; oxaliplatin 130 mg/m² intravenously every 3 weeks). This is followed by long-course chemoradiotherapy (LCRT): a total dose of 50.4 Gy delivered in 28 fractions, with concurrent capecitabine 825 mg/m² orally twice daily.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Camrelizumab combined LCRT Receives: Drug: Camrelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
CR rate
pCR+cCR
Measured: cCR is assessed at 4-6 weeks post-therapy by imaging/endoscopy; pCR is assessed postoperatively (surgery at 4-6 weeks post-therapy + pathology within 1-2 weeks after surgery).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start1 Feb 2026
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Rectal CancerStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dai, Guanghai, Chinese PLA General Hospital
- Investigators
- Guanghai Dai, MD, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07527026
- Sponsor's protocol ID
- 2026-004
- Status last verified
- Apr 2026
- First submitted
- 8 Apr 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- 2026-004
- Conditions
- Locally Advanced Rectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Feb 2029 (estimated)
- First posted
- 14 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Drug: CamrelizumabCamrelizumab combined LCRT |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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;
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Camrelizumabpatients first receive 2 cycles of camrelizumab combined with CAPOX (capecitabine 1000 mg/m² orally twice daily on days 1-14; oxaliplatin 130 mg/m² intravenously every 3 weeks). This is followed by long-course chemoradiotherapy (LCRT): a total dose of 50.4 Gy delivered in 28 fractions, with concurrent capecitabine 825 mg/m² orally twice daily. | Drug | experimental group |
Primary outcome
CR rate
Time frame: cCR is assessed at 4-6 weeks post-therapy by imaging/endoscopy; pCR is assessed postoperatively (surgery at 4-6 weeks post-therapy + pathology within 1-2 weeks after surgery).
pCR+cCR
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guanghai Dai, MD principal investigator
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Camrelizumab in people with Locally Advanced Rectal Cancer, run by Chinese PLA General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guanghai Dai, MD (+86 13801232381, 463043539@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CR rate (time frame: cCR is assessed at 4-6 weeks post-therapy by imaging/endoscopy; pCR is assessed postoperatively (surgery at 4-6 weeks post-therapy + pathology within 1-2 weeks after surgery).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.