Rectal Cancer PatientsPhase 2NCT07687433
Long-Course Concurrent Chemoradiotherapy With Adebrelimab and Apatinib as Neoadjuvant Therapy for Locally Advanced/Low-Lying Rectal Cancer Requiring Sphincter Preservation
A Phase 2 study testing Long-course concurrent chemoradiotherapy combined with Adebrelimab and Apatinib in people with Rectal Cancer Patients, run by Harbin Medical University at 1 site in China.
Trial summary
To observe and evaluate the efficacy and safety of neoadjuvant long-course concurrent chemoradiotherapy combined with Adebrelimab and Apatinib Mesylate in the treatment of locally advanced rectal cancer and low-lying rectal cancer with sphincter-preservation demand. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Cancer Patients
- What is being tested?
- Long-course concurrent chemoradiotherapy combined with Adebrelimab and Apatinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteChina
- Study dates
- 29 May 2026to 29 May 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
- Age: 18 to 75 years, male or female;
- Histologically or cytologically confirmed rectal cancer with measurable tumor lesion(s) (spiral CT or MRI scan ≥10 mm, meeting RECIST 1.1 criteria);
- Clinical stage: rectal cancer cT3-4N0M0 or cT1-4N+M0, and low rectal cancer with a sphincter-preservation requirement (distance from the anal verge <5 cm; stage T2N0M0);
- Expected survival >3 months;
- ECOG PS score: 0-1;
- No peritoneal metastasis or other distant metastasis;
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- No prior radiotherapy or immune checkpoint inhibitor therapy for rectal cancer;
- Adequate function of vital organs as required (without the use of any blood components or cell growth factors during screening):
- Absolute neutrophil count ≥1.5×10⁹/L; platelet count ≥80×10⁹/L; hemoglobin ≥8.5 g/dL; Thyroid-stimulating hormone (TSH) ≤1×ULN (if abnormal, T3 and T4 levels should also be assessed; patients with normal T3 and T4 levels may be enrolled); Bilirubin ≤1.5×ULN; ALT and AST ≤2.5×ULN; Serum creatinine ≤1.5×ULN;
- Women of childbearing potential must have a negative pregnancy test (β-HCG) before starting treatment. Women of childbearing potential and men (who are sexually active with women of childbearing potential) must agree to use effective contraception consistently during treatment and for 6 months after the last dose;
- Subjects voluntarily participate in the study and sign the informed consent form.
Who cannot join
- Prior pelvic or abdominal radiotherapy;
- Tumor expected to be unresectable after neoadjuvant therapy;
- Pregnant or breastfeeding women, or women/ men of childbearing potential who refuse to use contraceptive measures;
- History of other malignancies within the past 5 years, except for adequately treated cervical carcinoma in situ or cutaneous squamous cell carcinoma, or well-controlled basal cell carcinoma of the skin;
- Uncontrolled symptomatic brain metastases, or poorly controlled psychiatric disorders, or severe intellectual or cognitive impairment;
- Pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, or severely impaired pulmonary function;
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- Active, known, or suspected autoimmune disease. Subjects with stable conditions not requiring systemic immunosuppressive therapy are eligible, e.g., type 1 diabetes, hypothyroidism requiring hormone replacement therapy, and skin conditions not requiring systemic treatment (e.g., vitiligo, psoriasis, and alopecia);
- Congestive heart failure, uncontrolled arrhythmia, myocardial infarction within 6 months, unstable angina, stroke or transient ischemic attack, severe hypertension refractory to medication, or other conditions rendering the patient unable to tolerate surgery;
- Severe active infection requiring intravenous antibiotic therapy during the screening period;
- Known allergy to the study drug or any of its excipients, or a history of severe allergic reaction to other monoclonal antibodies;
- Clinically significant bleeding symptoms or a clear bleeding tendency within 3 months prior to enrollment;
- Hypertension that remains uncontrolled despite antihypertensive therapy prior to enrollment;
- Patients with dysphagia;
- Receipt of or planned receipt of live vaccines within 30 days prior to administration of adebrelimab;
- Known history of HIV infection, or active hepatitis B or hepatitis C;
- Inability to comply with the study protocol or to cooperate with follow-up;
- Other conditions that the investigator considers inappropriate for participation in this trial.
Trial locations and contacts
1 site in 1 country.
China1 site
No. 150, Haping Road, Nangang District, Harbin, Heilongjiang Province, China
Harbin, Heilongjiang, 158100
About this study
Official title: A Phase II Clinical Study of Long-Course Concurrent Chemoradiotherapy Combined With Adebrelimab and Apatinib as Neoadjuvant Therapy for Locally Advanced/Low-Lying Rectal Cancer With Sphincter-Preservation Demand
To observe and evaluate the efficacy and safety of neoadjuvant long-course concurrent chemoradiotherapy combined with Adebrelimab and Apatinib Mesylate in the treatment of locally advanced rectal cancer and low-lying rectal cancer with sphincter-preservation demand.
Read the detailed description
The pathological complete response (pCR) rate of standard neoadjuvant chemoradiotherapy for locally advanced rectal cancer (LARC) is only 10%-15%, and patients with low-lying rectal cancer face difficulties in sphincter preservation, with their quality of life severely compromised. Immune checkpoint inhibitors combined with chemoradiotherapy have demonstrated potential to improve pCR rates, with the NECTAR study reporting a pCR rate of 40% and the VOLTAGE-A study showing a pCR rate of 30% in MSS patients. Anti-angiogenic agents can reverse the immunosuppressive tumor microenvironment and exert synergistic antitumor effects when combined with chemoradiotherapy and immunotherapy. Based on the above background, this study is a single-center, single-arm phase II clinical trial designed to enroll 43 patients with locally advanced rectal cancer and low-lying rectal cancer with sphincter-preservation demand, to explore the efficacy and safety of neoadjuvant long-course concurrent chemoradiotherapy (45-50 Gy/25 fractions, concurrent capecitabine) combined with Adebrelimab (an anti-PD-L1 monoclonal antibody) and Apatinib Mesylate (an anti-angiogenic TKI). This study aims to provide rectal cancer patients with novel therapeutic strategies offering higher remission rates and greater opportunities for sphincter preservation.
- Conditions
- Rectal Cancer Patients
- Being tested
- Long-course concurrent chemoradiotherapy combined with Adebrelimab and Apatinib
- Keywords
- Adebrelimab, Neoadjuvant, Locally Advanced/Low-Lying Rectal Cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long-course concurrent chemoradiotherapy combined with Adebrelimab and ApatinibDrug
Long-course concurrent chemoradiotherapy regimen: 45-50 Gy administered in 25 fractions, with concurrent capecitabine 1650 mg/m²/day, bid on days 1-14, every 3 weeks as one cycle.
Adebrelimab: 1200 mg, intravenous infusion, on D1, once every 3 weeks.
Apatinib: 250 mg, orally, 5 days on and 2 days off; if the patient cannot tolerate the toxicity, the dose may be reduced to 125 mg once daily.
Each cycle is 21 days, with a total of 6 cycles of neoadjuvant therapy before surgery. Efficacy evaluation is performed after every 2 cycles. After 6 cycles of long-course concurrent chemoradiotherapy combined with Adebrelimab and Apatinib, the research team will reassess the patient. For resectable patients, surgery will be performed 4-6 weeks after neoadjuvant therapy. For patients who decline surgery or are deemed unfit for surgery after 6 cycles, if the investigator believes that continued treatment with Adebrelimab and Apatinib may still provide benefit, the treatment may be continued until
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Long-course concurrent chemoradiotherapy combined with Adebrelimab and Apatinib Receives: Drug: Long-course concurrent chemoradiotherapy combined with Adebrelimab and Apatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response Rate (cCR+pCR)
Proportion of patients achieving clinical complete response (cCR, no tumor residue by imaging and endoscopy) after neoadjuvant therapy or pathological complete response (pCR, no residual viable tumor cells in the tumor bed, %RVT=0) post-surgery.
Measured: cCR assessed after neoadjuvant therapy; pCR assessed within 2 weeks post-surgery; assessed up to 6 months.
Secondary outcomes (10)
Objective Response Rate (ORR)
Proportion of patients achieving complete response (CR) or partial response (PR) per RECIST 1.1 criteria on imaging.
Measured: Imaging assessment after every 2 cycles（21 days per cycle） of treatment and post-surgery; assessed up to 6 months.
Pathological Complete Response (pCR)
Proportion of patients with no residual viable tumor cells in the tumor bed (%RVT=0) after neoadjuvant therapy and surgery
Measured: Assessed via pathological examination of surgical specimens within 2 weeks post-surgery; assessed up to 6 months.
Tumor Regression Grade (TRG):
Assessment of pathological tumor regression grade per CAP criteria (grades 0-3), where grade 0 indicates complete regression (no viable tumor cells microscopically) and grade 3 indicates poor or no regression.
Measured: Assessed via pathological examination of surgical specimens within 2 weeks post-surgery; assessed up to 6 months.
Sphincter Preservation Rate
Proportion of patients with low-lying rectal cancer who successfully preserve the anal sphincter and undergo low/ultra-low anastomosis.
Measured: Assessed within 2 weeks post-surgery; assessed up to 6 months.
Disease-Free Survival (DFS)
Time from enrollment to disease recurrence or death due to disease progression.
Measured: Time from first treatment to recurrence or death (whichever occurs first), assessed up to 36 months.
Overall Survival (OS)
Time from first study drug administration to death from any cause.
Measured: Time from first treatment to death from any cause, assessed up to 36 months.
Adverse Event Rate
Incidence and severity of adverse events (AEs), serious adverse events (SAEs), and treatment-related adverse events (TRAEs) graded per NCI-CTCAE v6.0; surgical complications graded per Clavien-Dindo classification.
Measured: Continuous monitoring from informed consent to 90 days after the last dose; assessed up to 36 months.
Quality of Life (EORTC QLQ-CR29)
Assessment of bowel symptoms, sexual function, and overall quality of life; higher scores indicate worse symptoms or better function.
Measured: Assessed at baseline, pre-surgery post-neoadjuvant therapy, and at 3, 6, and 12 months post-surgery (5 time points in total); assessed up to 12 months.
Anal Function (LARS Score)
Assessment of low anterior resection syndrome, total score 0-42 (0-20: no/mild LARS; 21-29: moderate; 30-42: severe).
Measured: Assessed at baseline, pre-surgery post-neoadjuvant therapy, and at 3, 6, and 12 months post-surgery (5 time points in total);assessed up to 12 months.
Biomarker Exploration
Collection of tumor tissue and peripheral blood samples for genomic, transcriptomic, proteomic, and immune microenvironment analyses to identify potential predictive and prognostic biomarkers associated with efficacy and safety of neoadjuvant immunotherapy.
Measured: Baseline tumor tissue and peripheral blood collected. Peripheral blood sampled 3 times during treatment (pre-RT, post-RT, and pre-surgery); tissue collected once at baseline only. Assessed up to 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start29 May 2026
- Primary completion29 May 2028 (estimated)
- Study completion29 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal Cancer PatientsStudies 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
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunbo Zhao, Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07687433
- Sponsor's protocol ID
- SHR-1316-HLJ-014
- Status last verified
- Jun 2026
- First submitted
- 25 Jun 2026
- Last updated
- 7 Jul 2026
- 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 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Study of Long-Course Concurrent Chemoradiotherapy Combined With Adebrelimab and Apatinib as Neoadjuvant Therapy for Locally Advanced/Low-Lying Rectal Cancer With Sphincter-Preservation Demand
- ClinicalTrials.gov ID
- NCT07687433
- Acronym / sponsor ID
- SHR-1316-HLJ-014
- Conditions
- Rectal Cancer Patients
- Keywords
- Adebrelimab, Neoadjuvant, Locally Advanced/Low-Lying Rectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Harbin Medical UniversityUniversity, hospital or other
- Study start
- 29 May 2026 (actual)
- Primary completion
- 29 May 2028 (estimated)
- Study completion
- 29 May 2029 (estimated)
- First posted
- 7 Jul 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.
To observe and evaluate the efficacy and safety of neoadjuvant long-course concurrent chemoradiotherapy combined with Adebrelimab and Apatinib Mesylate in the treatment of locally advanced rectal cancer and low-lying rectal cancer with sphincter-preservation demand.
Detailed description
The pathological complete response (pCR) rate of standard neoadjuvant chemoradiotherapy for locally advanced rectal cancer (LARC) is only 10%-15%, and patients with low-lying rectal cancer face difficulties in sphincter preservation, with their quality of life severely compromised. Immune checkpoint inhibitors combined with chemoradiotherapy have demonstrated potential to improve pCR rates, with the NECTAR study reporting a pCR rate of 40% and the VOLTAGE-A study showing a pCR rate of 30% in MSS patients. Anti-angiogenic agents can reverse the immunosuppressive tumor microenvironment and exert synergistic antitumor effects when combined with chemoradiotherapy and immunotherapy. Based on the above background, this study is a single-center, single-arm phase II clinical trial designed to enroll 43 patients with locally advanced rectal cancer and low-lying rectal cancer with sphincter-preservation demand, to explore the efficacy and safety of neoadjuvant long-course concurrent chemoradiotherapy (45-50 Gy/25 fractions, concurrent capecitabine) combined with Adebrelimab (an anti-PD-L1 monoclonal antibody) and Apatinib Mesylate (an anti-angiogenic TKI). This study aims to provide rectal cancer patients with novel therapeutic strategies offering higher remission rates and greater opportunities for sphincter preservation.
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: Long-course concurrent chemoradiotherapy combined with Adebrelimab and ApatinibLong-course concurrent chemoradiotherapy combined with Adebrelimab and Apatinib |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age: 18 to 75 years, male or female;
- Histologically or cytologically confirmed rectal cancer with measurable tumor lesion(s) (spiral CT or MRI scan ≥10 mm, meeting RECIST 1.1 criteria);
- Clinical stage: rectal cancer cT3-4N0M0 or cT1-4N+M0, and low rectal cancer with a sphincter-preservation requirement (distance from the anal verge <5 cm; stage T2N0M0);
- Expected survival >3 months;
- ECOG PS score: 0-1;
Key exclusion criteria (17 listed)
- Prior pelvic or abdominal radiotherapy;
- Tumor expected to be unresectable after neoadjuvant therapy;
- Pregnant or breastfeeding women, or women/ men of childbearing potential who refuse to use contraceptive measures;
- History of other malignancies within the past 5 years, except for adequately treated cervical carcinoma in situ or cutaneous squamous cell carcinoma, or well-controlled basal cell carcinoma of the skin;
- Uncontrolled symptomatic brain metastases, or poorly controlled psychiatric disorders, or severe intellectual or cognitive impairment;
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 |
|---|---|---|
| Long-course concurrent chemoradiotherapy combined with Adebrelimab and ApatinibLong-course concurrent chemoradiotherapy regimen: 45-50 Gy administered in 25 fractions, with concurrent capecitabine 1650 mg/m²/day, bid on days 1-14, every 3 weeks as one cycle. Adebrelimab: 1200 mg, intravenous infusion, on D1, once every 3 weeks. Apatinib: 250 mg, orally, 5 days on and 2 days off; if the patient cannot tolerate the toxicity, the dose may be reduced to 125 mg once daily. Each cycle is 21 days, with a total of 6 cycles of neoadjuvant therapy before surgery. Efficacy evaluation is performed after every 2 cycles. After 6 cycles of long-course concurrent chemoradiotherapy combined with Adebrelimab and Apatinib, the research team will reassess the patient. For resectable patients, surgery will be performed 4-6 weeks after neoadjuvant therapy. For patients who decline surgery or are deemed unfit for surgery after 6 cycles, if the investigator believes that continued treatment with Adebrelimab and Apatinib may still provide benefit, the treatment may be continued until | Drug | Treatment arm |
Primary outcome
Complete Response Rate (cCR+pCR)
Time frame: cCR assessed after neoadjuvant therapy; pCR assessed within 2 weeks post-surgery; assessed up to 6 months.
Proportion of patients achieving clinical complete response (cCR, no tumor residue by imaging and endoscopy) after neoadjuvant therapy or pathological complete response (pCR, no residual viable tumor cells in the tumor bed, %RVT=0) post-surgery.
10 secondary outcomes
Objective Response Rate (ORR)
Time frame: Imaging assessment after every 2 cycles（21 days per cycle） of treatment and post-surgery; assessed up to 6 months.
Pathological Complete Response (pCR)
Time frame: Assessed via pathological examination of surgical specimens within 2 weeks post-surgery; assessed up to 6 months.
Tumor Regression Grade (TRG):
Time frame: Assessed via pathological examination of surgical specimens within 2 weeks post-surgery; assessed up to 6 months.
Sphincter Preservation Rate
Time frame: Assessed within 2 weeks post-surgery; assessed up to 6 months.
Disease-Free Survival (DFS)
Time frame: Time from first treatment to recurrence or death (whichever occurs first), assessed up to 36 months.
Overall Survival (OS)
Time frame: Time from first treatment to death from any cause, assessed up to 36 months.
Adverse Event Rate
Time frame: Continuous monitoring from informed consent to 90 days after the last dose; assessed up to 36 months.
Quality of Life (EORTC QLQ-CR29)
Time frame: Assessed at baseline, pre-surgery post-neoadjuvant therapy, and at 3, 6, and 12 months post-surgery (5 time points in total); assessed up to 12 months.
Anal Function (LARS Score)
Time frame: Assessed at baseline, pre-surgery post-neoadjuvant therapy, and at 3, 6, and 12 months post-surgery (5 time points in total);assessed up to 12 months.
Biomarker Exploration
Time frame: Baseline tumor tissue and peripheral blood collected. Peripheral blood sampled 3 times during treatment (pre-RT, post-RT, and pre-surgery); tissue collected once at baseline only. Assessed up to 6 months.
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 7 Jul 2026.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Long-course concurrent chemoradiotherapy combined with Adebrelimab and Apatinib in people with Rectal Cancer Patients, run by Harbin Medical University 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 17 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: under way, not looking for participants, as of the sponsor's last update on 7 Jul 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Response Rate (cCR+pCR) (time frame: cCR assessed after neoadjuvant therapy; pCR assessed within 2 weeks post-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 7 Jul 2026.