Locally Advanced Resectable Rectal CancerPhase 2NCT07905950
Exploratory Study of Short-Course Radiotherapy Followed by Adebrelimab Combined With Chemotherapy for Organ Preservation in Locally Advanced Rectal Cancer
A Phase 2 study testing Adebrelimab in people with Locally Advanced Resectable Rectal Cancer, run by Henan Cancer Hospital at 1 site in China.
Trial summary
This prospective, single-arm, exploratory clinical study aims to evaluate the efficacy and safety of short-course radiotherapy (SCRT) sequentially followed by adebrelimab combined with chemotherapy as an organ-preservation strategy in patients with locally advanced resectable rectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Resectable Rectal Cancer
- What is being tested?
- Adebrelimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2026to 31 Oct 2031
- 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
- 1. Age 18-75 years, of either sex;
- 2. Stage II/III disease (cT3-T4N0 or cT2-4N+, without distant metastasis, per the 8th edition of the AJCC Cancer Staging Manual, 2018) as assessed by magnetic resonance imaging (MRI) or endoscopic ultrasound (EUS);
- 3. The lower border of the lesion located ≤10 cm from the anal verge, as assessed by fiberoptic colonoscopy or digital rectal examination;
- 4. Histologically confirmed or centrally reviewed rectal adenocarcinoma;
- 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- 6. Hematologic and biochemical parameters meeting the following criteria within 7 days prior to enrollment:
Show all 18Show fewer
- Hemoglobin ≥90 g/L; absolute neutrophil count (ANC) ≥1.5×10⁹/L; white blood cell count (WBC) ≥3.5×10⁹/L; platelet count ≥100×10⁹/L (patients must not have received blood transfusion or growth factor support within 14 days prior to blood sample collection);
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5× the upper limit of normal (ULN); alkaline phosphatase (ALP) ≤2.5× ULN;
- Serum total bilirubin <1.5× ULN (patients with Gilbert's syndrome may be enrolled if total bilirubin <3× ULN);
- Serum creatinine <1.5× ULN or estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 m²;
- Serum albumin ≥30 g/L;
- International normalized ratio (INR) or prothrombin time (PT) ≤1.5× ULN, unless the patient is receiving anticoagulant therapy and the PT value is within the expected therapeutic range of the anticoagulant;
- Activated partial thromboplastin time (APTT) ≤1.5× ULN.
- 7. Left ventricular ejection fraction (LVEF) ≥ the lower limit of normal (50%), as assessed by Doppler echocardiography;
- 8. No history of allergy to 5-fluorouracil (5-FU)-based agents or platinum-based agents;
- 9. Patients with primary rectal cancer must not have received surgery (except palliative ostomy), chemotherapy, or other anti-tumor therapy from the time of diagnosis to enrollment;
- 10. No prior radiotherapy to the planned radiation field;
- 11. Written informed consent provided.
Who cannot join
- 1. Prior treatment with anti-PD-1/PD-L1 or anti-CTLA-4 immunotherapeutic agents, or other investigational immunotherapy drugs;
- 2. Patients with severe autoimmune diseases: active inflammatory bowel disease (including Crohn's disease and ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (e.g., granulomatosis with polyangiitis), etc.;
- 3. Symptomatic interstitial lung disease or active infectious/non-infectious pneumonitis;
- 4. Patients with risk factors for bowel perforation: active diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, abdominal cancer, or other known risk factors for bowel perforation;
- 5. History of other malignancies, excluding curable non-melanoma skin cancer and carcinoma in situ of the cervix;
- 6. Patients with active infection, heart failure, myocardial infarction within the past 6 months, unstable angina, or unstable arrhythmia;
Show all 14Show fewer
- 7. Physical examination or clinical laboratory findings, or other uncontrolled diseases that, in the investigator's judgment, may interfere with the study results or increase the risk of treatment complications for the patient;
- 8. Women who are pregnant or breastfeeding;
- 9. Congenital or acquired immunodeficiency disorders, including human immunodeficiency virus (HIV) infection, or a history of organ transplantation or allogeneic stem cell transplantation;
- 10. Known active hepatitis B virus (HBV) infection (HBV-DNA ≥2000 U/mL), hepatitis C virus (HCV) infection, or active pulmonary tuberculosis;
- 11. Patients who have previously received a tumor vaccine, or who have received other vaccines within 4 weeks prior to initiation of study treatment (Note: injectable seasonal influenza vaccines, which are mostly inactivated vaccines, are permitted; intranasal formulations, which are usually live attenuated vaccines, are not permitted);
- 12. Patients concurrently receiving other immunomodulatory agents, chemotherapeutic agents, investigational drugs from other clinical studies, or requiring long-term corticosteroid therapy are not eligible for enrollment;
- 13. Patients with psychiatric disorders, substance abuse, or social issues that may affect compliance are excluded at the discretion of the investigator;
- 14. Patients with allergy to or contraindications for the study treatment drugs.
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
Henan Cancer Hospital
Zhengzhou, Henan
Xiushen Wang, 13526649066, wangxiushen1218@163.com
About this study
Official title: An Exploratory Clinical Study Investigating Organ-Preserving Strategy With Short-Course Radiotherapy Followed by Adebrelimab Plus Chemotherapy in Patients With Locally Advanced Rectal Cancer
This prospective, single-arm, exploratory clinical study aims to evaluate the efficacy and safety of short-course radiotherapy (SCRT) sequentially followed by adebrelimab combined with chemotherapy as an organ-preservation strategy in patients with locally advanced resectable rectal cancer. Approximately 155 eligible patients will be enrolled after providing full written informed consent and passing screening, and will receive SCRT followed by adebrelimab plus chemotherapy. The primary efficacy endpoint is the complete response (CR) rate assessed at the end of Cycle 4 or Cycle 8 of treatment. Efficacy evaluation will be conducted after 4 cycles of treatment, and subsequent treatment regimens will be determined according to each patient's condition.
- Being tested
- Adebrelimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdebrelimabDrug
SCRT followed by adebrelimab plus chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| treatment arm | Experimental | Not described Receives: Drug: Adebrelimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
the complete response (CR) rate assessed at the end of Cycle 4 or Cycle 8
Measured: at the end of Cycle 4 or Cycle 8(each cycle is 21 days).
Secondary outcomes (9)
The 3-year event-free survival (EFS) rate
Measured: At 36 months after treatment initiation.
3-year overall survival (OS) rate
Measured: At 36 months after treatment initiation.
The median event-free survival (mEFS)
Measured: From date of treatment initiation until the first documented disease progression, recurrence, or death from any cause, whichever occurs first, up to 60 months.
The median overall survival (mOS)
Measured: From date of treatment initiation until death from any cause, , up to 60 months.
The local recurrence rate (LRR)
Measured: Within 3 years after treatment initiation.
R0 resection rate
Measured: At the time of surgery.
distant metastasis rate (DM)
Measured: Within 3 years after treatment initiation.
The organ preservation rate
Measured: Within 3 years after treatment initiation.
incidence of adverse events (AEs)
Measured: From date of treatment initiation until 30 days after the last dose of study treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Oct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Resectable Rectal CancerStudies of the same condition, open and under way.
- More trials run by Henan Cancer 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
- 155 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Wang, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07905950
- Sponsor's protocol ID
- ADE-LARC-OP01
- Status last verified
- Oct 2026
- First submitted
- 21 Sep 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study Investigating Organ-Preserving Strategy With Short-Course Radiotherapy Followed by Adebrelimab Plus Chemotherapy in Patients With Locally Advanced Rectal Cancer
- ClinicalTrials.gov ID
- NCT07905950
- Acronym / sponsor ID
- ADE-LARC-OP01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 155 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 31 Oct 2031 (estimated)
- First posted
- 30 Oct 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.
This prospective, single-arm, exploratory clinical study aims to evaluate the efficacy and safety of short-course radiotherapy (SCRT) sequentially followed by adebrelimab combined with chemotherapy as an organ-preservation strategy in patients with locally advanced resectable rectal cancer. Approximately 155 eligible patients will be enrolled after providing full written informed consent and passing screening, and will receive SCRT followed by adebrelimab plus chemotherapy. The primary efficacy endpoint is the complete response (CR) rate assessed at the end of Cycle 4 or Cycle 8 of treatment. Efficacy evaluation will be conducted after 4 cycles of treatment, and subsequent treatment regimens will be determined according to each patient's condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment arm | Experimental | Drug: Adebrelimab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 1. Age 18-75 years, of either sex;
- 2. Stage II/III disease (cT3-T4N0 or cT2-4N+, without distant metastasis, per the 8th edition of the AJCC Cancer Staging Manual, 2018) as assessed by magnetic resonance imaging (MRI) or endoscopic ultrasound (EUS);
- 3. The lower border of the lesion located ≤10 cm from the anal verge, as assessed by fiberoptic colonoscopy or digital rectal examination;
- 4. Histologically confirmed or centrally reviewed rectal adenocarcinoma;
- 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
Key exclusion criteria (14 listed)
- 1. Prior treatment with anti-PD-1/PD-L1 or anti-CTLA-4 immunotherapeutic agents, or other investigational immunotherapy drugs;
- 2. Patients with severe autoimmune diseases: active inflammatory bowel disease (including Crohn's disease and ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (e.g., granulomatosis with polyangiitis), etc.;
- 3. Symptomatic interstitial lung disease or active infectious/non-infectious pneumonitis;
- 4. Patients with risk factors for bowel perforation: active diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, abdominal cancer, or other known risk factors for bowel perforation;
- 5. History of other malignancies, excluding curable non-melanoma skin cancer and carcinoma in situ of the cervix;
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 |
|---|---|---|
| AdebrelimabSCRT followed by adebrelimab plus chemotherapy | Drug | treatment arm |
Primary outcome
the complete response (CR) rate assessed at the end of Cycle 4 or Cycle 8
Time frame: at the end of Cycle 4 or Cycle 8(each cycle is 21 days).
9 secondary outcomes
The 3-year event-free survival (EFS) rate
Time frame: At 36 months after treatment initiation.
3-year overall survival (OS) rate
Time frame: At 36 months after treatment initiation.
The median event-free survival (mEFS)
Time frame: From date of treatment initiation until the first documented disease progression, recurrence, or death from any cause, whichever occurs first, up to 60 months.
The median overall survival (mOS)
Time frame: From date of treatment initiation until death from any cause, , up to 60 months.
The local recurrence rate (LRR)
Time frame: Within 3 years after treatment initiation.
R0 resection rate
Time frame: At the time of surgery.
distant metastasis rate (DM)
Time frame: Within 3 years after treatment initiation.
The organ preservation rate
Time frame: Within 3 years after treatment initiation.
incidence of adverse events (AEs)
Time frame: From date of treatment initiation until 30 days after the last dose of study treatment.
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 30 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Locally Advanced Resectable Rectal Cancer
RecruitingPhase 2
A Single-Arm, Phase II, Multicenter Clinical Study of Neoadjuvant Encorafenib Plus Cetuximab N01 and mFOLFOX6 in Patients With Locally Advanced BRAF V600E-Mutant Colorectal Cancer With or Without Resectable Metastases
Colorectal Cancer, BRAF V600E Mutation Positive
Not yet recruitingPhase 3
Study Evaluating Two Treatment Strategies for Rectal Cancer in Patients ≥75 Years Old
Locally Advanced Rectal Adenocarcinoma
RecruitingPhase 2
Neoadjuvant Treatment of Fulzerasib Plus Cetuximab N01 in KRAS G12C Mutated Locally Advanced Colorectal Cancer With or Without Resectable Metastases
Colorectal Cancer, KRAS G12C Mutant Advanced Solid Tumors
RecruitingPhase 2/3
A Clinical Study of Adebrelimab in Combination With SHR-8068 and Chemoradiotherapy as Perioperative Therapy for Locally Advanced Rectal Cancer
Locally Advanced Resectable Rectal Cancer
RecruitingPhase 3
Non Inferiority Study of Preoperative Chemotherapy Without Pelvic Irradiation for Rectal Cancer
Rectal Cancer, Advanced Cancer
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.
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 Adebrelimab in people with Locally Advanced Resectable Rectal Cancer, run by Henan Cancer 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 18 inclusion and 14 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: opening soon, as of the sponsor's last update on 30 Oct 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 Xiushen Wang (13526649066, wangxiushen1218@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the complete response (CR) rate assessed at the end of Cycle 4 or Cycle 8 (time frame: at the end of Cycle 4 or Cycle 8(each cycle is 21 days).). 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 30 Oct 2026.