Rectal CancerPhase 2NCT06765616
Adebrelimab Injection (PD-L1) Combined With Short Course Radiotherapy and Chemotherapy for Neoadjuvant Therapy of Locally Advanced Rectal Cancer
A Phase 2 study testing Adebrelimab Injection combined with radiotherapy and chemotherapy in people with Rectal Cancer and Advanced Stage Colorectal Cancer, run by Feng Tian at 1 site in China.
Trial summary
This study is a multicenter, single arm, prospective study aimed at evaluating the efficacy and safety of adebelimab combined with short course radiotherapy (5 * 5Gy) and chemotherapy as preoperative neoadjuvant therapy for locally advanced rectal cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Rectal Cancer, Advanced Stage Colorectal Cancer, Radiotherapy
- What is being tested?
- Adebrelimab Injection combined with radiotherapy and chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 1 Jul 2026
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sign written informed consent before implementing any experimental procedures;
- Male or female, aged 18 or above and 85 or below;
- Patients diagnosed with rectal adenocarcinoma through primary lesion biopsy and histopathological examination;
- Patients with cT stage ≥ T3 or cN stage N1+, M0 or EMVI (+) or MRF (+) or suspected lateral lymph node metastasis (>5mm) who are determined to be operable and require neoadjuvant therapy through imaging and colonoscopy examination.
- According to imaging and colonoscopy examination, the main body of the patient's tumor is located ≤ 15cm away from the anal edge;
- According to the criteria for evaluating the efficacy of solid tumors (RECIST version 1.1), there should be at least one measurable lesion on imaging;
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- The patient has not received any anti-tumor treatment in the past, including but not limited to surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, etc;
- ECOG score 0-1 points;
- Adequate organ function, subjects must meet the following laboratory indicators:
- In the past 14 days without using granulocyte colony-stimulating factor, the absolute neutrophil count (ANC) was ≥ 1.5x109/L.
- Platelets ≥ 100 × 109/L without blood transfusion in the past 14 days.
- Hemoglobin>9g/dL in the past 14 days without blood transfusion or use of erythropoietin;
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN);
- Aspartate transaminase (AST) and alanine transaminase (ALT) levels are ≤ 2.5 × ULN
- Blood creatinine ≤ 1.5 × ULN and creatinine clearance rate (calculated using Cockcroft Gault formula) ≥ 60 ml/min;
- Good coagulation function, defined as International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 times ULN;
- Normal thyroid function is defined as thyroid stimulating hormone (TSH) within the normal range. If the baseline TSH exceeds the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled;
- The myocardial enzyme spectrum is within the normal range (simple laboratory abnormalities that are deemed clinically insignificant by the researchers are also allowed to be included)
- For female subjects of childbearing age, a urine or serum pregnancy test with negative results should be conducted within 3 days prior to the first administration of the study drug (Day 1 of the first cycle). If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Non childbearing women are defined as those who have been postmenopausal for at least one year or have undergone surgical sterilization or hysterectomy; If there is a risk of conception, all subjects (male or female) must use contraceptive measures with an annual failure rate of less than 1% throughout the entire treatment period until 120 days after the last administration of the study drug (or 180 days after the last administration of chemotherapy drug).
Who cannot join
- Patients diagnosed with other malignant tumors that have not been cured within 5 years before the first administration (excluding skin basal cell carcinoma, squamous cell carcinoma, and/or carcinoma in situ that has undergone radical resection);
- Late stage rectal cancer patients with distant metastasis;
- Currently participating in interventional clinical research treatment, or having received other research drugs or used research instruments for treatment within 4 weeks before the first administration;
- Previously received the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs, or drugs that stimulate or synergistically inhibit T cell receptors (such as CTLA-4, OX-40, CD137);
- Have received systemic treatment of traditional Chinese patent medicines and simple preparations with anti-tumor indications or drugs with immunomodulatory effect within 2 weeks before the first administration;
- Within 2 years prior to the first administration, there has been an active autoimmune disease requiring systemic treatment (such as the use of disease relieving drugs, corticosteroids, or immunosuppressants). Alternative therapies (such as thyroid hormone, insulin, or physiological glucocorticoids used for adrenal or pituitary insufficiency) are not considered systemic treatments;
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- Within 7 days prior to the first administration of the study, the individual was receiving systemic corticosteroid therapy (excluding topical corticosteroids via nasal spray, inhalation, or other routes) or any other form of immunosuppressive therapy;Note: Physiological doses of glucocorticoids (≤ 10 mg/day of prednisone or equivalent) are allowed to be used;
- Known allogeneic organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation;
- Those who are known to be allergic to the active ingredients or excipients of the investigational drug Adabelimab and combination chemotherapy drugs;
- Prior to commencing treatment, the individual has not fully recovered from any toxicity and/or complications caused by any intervention measures (i.e., ≤ grade 1 or baseline, excluding fatigue or hair loss);
- Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive);
- Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number detected is greater than the upper limit of normal value in the laboratory of the research center);Note: hepatitis B patients who meet the following criteria can also be included in the group:
- Prior to the first administration, if the HBV viral load is less than 1000 copies/ml (200 IU/ml), subjects should receive anti HBV treatment throughout the entire study chemotherapy period to avoid viral reactivation
- For subjects with anti HBc (+), HBsAg (-), anti HBs (-), and HBV viral load (-), prophylactic anti HBV treatment is not necessary, but close monitoring of viral reactivation is necessary
- Active HCV infected subjects (HCV antibody positive and HCV-RNA level above the detection limit);
- Administer a live vaccine within 30 days prior to the first dose (Day 1 of the first cycle);Note: It is allowed to receive inactivated vaccine for seasonal influenza within 30 days before the first administration; However, intranasal administration of attenuated live influenza vaccine is not allowed.
- Pregnant or lactating women;
- There are any serious or uncontrollable systemic diseases, such as:
- Resting electrocardiogram shows significant and difficult to control abnormalities in rhythm, conduction, or morphology, such as complete left bundle branch block, grade II or higher heart block, ventricular arrhythmia, or atrial fibrillation;
- Unstable angina pectoris, congestive heart failure, chronic heart failure classified as NYHA ≥ 2;
- Myocardial infarction occurred within 6 months prior to enrollment;
- Poor blood pressure control (systolic blood pressure>140 mmHg, diastolic blood pressure>90 mmHg);
- A history of non infectious pneumonia requiring corticosteroid treatment within the year prior to the first administration, or current clinical active interstitial lung disease;
- Active pulmonary tuberculosis;
- There are active or uncontrolled infections that require systemic treatment;
- There is clinical active diverticulitis, abdominal abscess, and gastrointestinal obstruction;
- Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis;
- Poor control of diabetes (FBG>10mmol/L);
- Urine routine shows urinary protein ≥++and confirms 24-hour urinary protein quantification>1.0 g;
- Patients with mental disorders who are unable to cooperate with treatment;
- Medical history or disease evidence, abnormal treatment or laboratory test values that may interfere with the trial results, hinder the full participation of the subjects in the study, or other situations that the researchers believe are not suitable for inclusion. The researchers believe that there are other potential risks and they are not suitable to participate in this study.
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
Shandong Provincial Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, 250021
Feng Tian, Dr, +86 18866102886, tianfeng@sdu.edu.cn
About this study
Official title: Adebrelimab Injection (PD-L1) Combined With Short Course Radiotherapy and Chemotherapy for Neoadjuvant Therapy of Locally Advanced Rectal Cancer: a Multicenter, Single Arm Prospective Study
This study is a multicenter, single arm, prospective study aimed at evaluating the efficacy and safety of adebelimab combined with short course radiotherapy (5 * 5Gy) and chemotherapy as preoperative neoadjuvant therapy for locally advanced rectal cancer patients. In the study, all subjects who met the inclusion criteria will receive a combination of adebelimab, short course radiotherapy (5 * 5Gy), and CAPOX chemotherapy as neoadjuvant therapy according to the study plan. TME surgery will be performed 2-3 weeks after the last dose of neoadjuvant therapy. If the surgery cannot be performed within the time window specified in the protocol (such as delayed adverse reactions, etc.), the researcher will consider the actual clinical situation of the subjects comprehensively.
- Being tested
- Adebrelimab Injection combined with radiotherapy and chemotherapy
- Keywords
- Immune checkpoint inhibitors；Adebrelimab Injection
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adebrelimab Injection combined with radiotherapy and chemotherapyDrug
Radiotherapy regimen: SCRT short-term radiotherapy of 5 × 5Gy Immunotherapy regimen: Adebrelimab Injection 1200 mg or 20 mg/kg, iv., followed by administration on the 1st day of each subsequent chemotherapy cycle.
Chemotherapy regimen: CAPOX regimen (chemotherapy cycle d1, to chemotherapy cycle d14):
Oxaliplatin 130 mg/m2 iv d1
Capecitabine 1000 mg/m2 po bid d1~14
Repeat every 3 weeks for 6 cycles
After completing 6 cycles of chemotherapy, the patient underwent TME surgery 2-3 weeks later.
| Study group | Role | What they receive |
|---|---|---|
| Adebrelimab Injection combined with radiotherapy and chemotherapy | Experimental | Radiotherapy regimen: SCRT short-term radiotherapy of 5 × 5Gy Immunotherapy regimen: Adebrelimab Injection 1200 mg or 20 mg/kg, iv., followed by administration on the 1st day of each subsequent chemotherapy cycle.
Chemotherapy regimen: CAPOX regimen (chemotherapy cycle d1, to chemotherapy cycle d14):
Oxaliplatin 130 mg/m2 iv d1
Capecitabine 1000 mg/m2 po bid d1~14
Repeat every 3 weeks for 6 cycles
After completing 6 cycles of chemotherapy, the patient underwent TME surgery 2-3 weeks later. Receives: Drug: Adebrelimab Injection combined with radiotherapy and chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete remission rate (pCR)
Pathological complete remission rate (pCR)
Measured: From enrollment to the end of surgery,assessed up to 6 months
Secondary outcomes (4)
Objective response rate (ORR)
Objective response rate (ORR)
Measured: The evaluation time from enrollment to the first efficacy evaluation is up to 3 months
Major Pathological Response Rate (MPR)
Major Pathological Response Rate (MPR)
Measured: From enrollment to the end of surgery,assessed up to 6 months
R0 resection rate
R0 resection rate
Measured: From enrollment to the end of surgery,assessed up to 6 months
Adverse reaction incidence rate
Adverse reaction incidence rate
Measured: From enrollment to 90 days after the last medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start1 Jan 2024
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- 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
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Feng Tian
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Feng Tian, Shandong Provincial Hospital
- Investigators
- Changqing Jing, Professor, Study director, Shandong Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06765616
- Sponsor's protocol ID
- 23-OBU-SD-CRC-II-004
- Status last verified
- Jan 2025
- First submitted
- 22 Dec 2024
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- 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 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adebrelimab Injection (PD-L1) Combined With Short Course Radiotherapy and Chemotherapy for Neoadjuvant Therapy of Locally Advanced Rectal Cancer: a Multicenter, Single Arm Prospective Study
- ClinicalTrials.gov ID
- NCT06765616
- Acronym / sponsor ID
- 23-OBU-SD-CRC-II-004
- Keywords
- Immune checkpoint inhibitors；Adebrelimab Injection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Feng TianOther government
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 9 Jan 2025 (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 study is a multicenter, single arm, prospective study aimed at evaluating the efficacy and safety of adebelimab combined with short course radiotherapy (5 * 5Gy) and chemotherapy as preoperative neoadjuvant therapy for locally advanced rectal cancer patients. In the study, all subjects who met the inclusion criteria will receive a combination of adebelimab, short course radiotherapy (5 * 5Gy), and CAPOX chemotherapy as neoadjuvant therapy according to the study plan. TME surgery will be performed 2-3 weeks after the last dose of neoadjuvant therapy. If the surgery cannot be performed within the time window specified in the protocol (such as delayed adverse reactions, etc.), the researcher will consider the actual clinical situation of the subjects comprehensively.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adebrelimab Injection combined with radiotherapy and chemotherapy | Experimental | Drug: Adebrelimab Injection combined with radiotherapy and chemotherapyRadiotherapy regimen: SCRT short-term radiotherapy of 5 × 5Gy Immunotherapy regimen: Adebrelimab Injection 1200 mg or 20 mg/kg, iv., followed by administration on the 1st day of each subsequent chemotherapy cycle. Chemotherapy regimen: CAPOX regimen (chemotherapy cycle d1, to chemotherapy cycle d14): Oxaliplatin 130 mg/m2 iv d1 Capecitabine 1000 mg/m2 po bid d1~14 Repeat every 3 weeks for 6 cycles After completing 6 cycles of chemotherapy, the patient underwent TME surgery 2-3 weeks later. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Sign written informed consent before implementing any experimental procedures;
- Male or female, aged 18 or above and 85 or below;
- Patients diagnosed with rectal adenocarcinoma through primary lesion biopsy and histopathological examination;
- Patients with cT stage ≥ T3 or cN stage N1+, M0 or EMVI (+) or MRF (+) or suspected lateral lymph node metastasis (>5mm) who are determined to be operable and require neoadjuvant therapy through imaging and colonoscopy examination.
- According to imaging and colonoscopy examination, the main body of the patient's tumor is located ≤ 15cm away from the anal edge;
Key exclusion criteria (31 listed)
- Patients diagnosed with other malignant tumors that have not been cured within 5 years before the first administration (excluding skin basal cell carcinoma, squamous cell carcinoma, and/or carcinoma in situ that has undergone radical resection);
- Late stage rectal cancer patients with distant metastasis;
- Currently participating in interventional clinical research treatment, or having received other research drugs or used research instruments for treatment within 4 weeks before the first administration;
- Previously received the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs, or drugs that stimulate or synergistically inhibit T cell receptors (such as CTLA-4, OX-40, CD137);
- Have received systemic treatment of traditional Chinese patent medicines and simple preparations with anti-tumor indications or drugs with immunomodulatory effect within 2 weeks before the first administration;
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 |
|---|---|---|
| Adebrelimab Injection combined with radiotherapy and chemotherapyRadiotherapy regimen: SCRT short-term radiotherapy of 5 × 5Gy Immunotherapy regimen: Adebrelimab Injection 1200 mg or 20 mg/kg, iv., followed by administration on the 1st day of each subsequent chemotherapy cycle. Chemotherapy regimen: CAPOX regimen (chemotherapy cycle d1, to chemotherapy cycle d14): Oxaliplatin 130 mg/m2 iv d1 Capecitabine 1000 mg/m2 po bid d1~14 Repeat every 3 weeks for 6 cycles After completing 6 cycles of chemotherapy, the patient underwent TME surgery 2-3 weeks later. | Drug | Adebrelimab Injection combined with radiotherapy and chemotherapy |
Primary outcome
Pathological complete remission rate (pCR)
Time frame: From enrollment to the end of surgery,assessed up to 6 months
Pathological complete remission rate (pCR)
4 secondary outcomes
Objective response rate (ORR)
Time frame: The evaluation time from enrollment to the first efficacy evaluation is up to 3 months
Major Pathological Response Rate (MPR)
Time frame: From enrollment to the end of surgery,assessed up to 6 months
R0 resection rate
Time frame: From enrollment to the end of surgery,assessed up to 6 months
Adverse reaction incidence rate
Time frame: From enrollment to 90 days after the last medication
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 9 Jan 2025.
- Individual participant dataSharing planned: No
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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.
Changqing Jing, Professor study director
Shandong Provincial 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 Adebrelimab Injection combined with radiotherapy and chemotherapy in people with Rectal Cancer and Advanced Stage Colorectal Cancer, run by Feng Tian 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 19 inclusion and 31 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 9 Jan 2025. 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 Feng Tian, Dr. (+86 18866102886, tianfeng@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete remission rate (pCR) (time frame: From enrollment to the end of surgery,assessed up to 6 months). 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 9 Jan 2025.