Pathological Complete ResponsePhase 2NCT07127497
Clinical Study on the Safety and Relationship of Sintilimab Combined With Chemotherapy in Neoadjuvant Treatment of Locally Advanced Rectal Adenocarcinoma
A Phase 2 study testing Sintilimab combined with XELOX in people with Pathological Complete Response and Rectal Cancer, run by The First Affiliated Hospital of Anhui Medical University at 1 site in China.
Trial summary
This study is designed as a single-center, phase II exploratory clinical trial to evaluate the pathological response rate and safety of sintilimab (PD-1 inhibitor) combined with XELOX regimen (oxaliplatin + capecitabine) for neoadjuvant treatment of LARC. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pathological Complete Response, Rectal Cancer, Neoadjuvant Chemoimmunotherapy
- What is being tested?
- Sintilimab combined with XELOX
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2022to 1 Oct 2028
- 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
Inclusion Criteria:1. Pathologically confirmed rectal adenocarcinoma (non-special type and special type, including mucinous adenocarcinoma, signet ring cell carcinoma, serrated adenocarcinoma, micropapillary carcinoma, medullary carcinoma, cribriform comedo adenocarcinoma); preoperative imaging confirmed that the stage is 1) rectal cancer T3 and (or) N+ resectable rectal cancer patients; 2) for T4 patients, re-evaluation of resectability must be conducted after the completion of neoadjuvant therapy, and radiotherapy may be used in combination depending on the situation. 2. Age ≥ 18 years old, gender is not limited, ECOG score 0-2 points; 3. Physical condition and organ function allow for major abdominal surgery/4. Agree that the researchers use blood, stool and pathological sections for research during the study; 5. Major organ function meets the following requirements (laboratory test values within 7 days before enrollment must meet the following standards) ① Routine blood examination: (no blood transfusion, no use of granulocyte colony stimulating factor, no use of drug correction within 14 days before screening): a) Neutrophil ≥ 1.5×109/L; b) Platelet ≥ 75×109/L; c) Hemoglobin ≥ 90g/L; ② Biochemical examination: (no albumin transfusion within 14 days before screening): a) Serum creatinine ≤ 1.5×upper limit of normal (ULN), or creatinine clearance> 50 mL/min; b) Serum total bilirubin ≤ 1.5×ULN; c) Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 × ULN; ③ Coagulation function: a) International normalized ratio (INR) ≤ 2.3 or prothrombin time (PT) exceeds the normal control range ≤ 6 seconds. 6. Patients are recruited regardless of their programmed death ligand 1 (PD-L1) expression level. -
Exclusion Criteria:1) The tumor has distant metastasis or peritoneal metastasis confirmed by laparoscopy; 2) Patients with other severe immunosuppressive diseases or other malignant tumors; 3) Any condition that affects the intestinal absorption of capecitabine; 4) Severe uncontrolled recurrent infections, or other serious uncontrolled concomitant diseases; severe mental illness; severe respiratory diseases; severe liver and kidney dysfunction; history of unstable angina or myocardial infarction within 6 months; history of cerebral infarction or cerebral hemorrhage within 6 months; continuous use of glucocorticoids within 1 month (except local application); 5) The researcher determines that the patient has other complications that endanger the patient's safety or may affect the completion of the study; 6) Currently or previously received other research drugs or any immunotherapy; 7) Suffering from malignant tumors in other parts within five years; 8) The patient is pregnant or lactating;
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Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022
About this study
Official title: Safety and Efficacy Evaluation of Neoadjuvant Chemotherapy Without Radiotherapy Combined With Sintilimab for Locally Advanced Rectal Cancer: Short-term Results of a Single-arm Phase 2 Trial
This study is designed as a single-center, phase II exploratory clinical trial to evaluate the pathological response rate and safety of sintilimab (PD-1 inhibitor) combined with XELOX regimen (oxaliplatin + capecitabine) for neoadjuvant treatment of LARC. The study focuses on the pMMR/MSS patient population and attempts to provide a new treatment option for patients who cannot tolerate radiotherapy or need to preserve organ function.
- Being tested
- Sintilimab combined with XELOX
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sintilimab combined with XELOXBiological
Sintilimab (3 mg/kg, IV, qd for patients with body weight < 60 kg; 200 mg, IV, qd for patients with body weight ≥ 60 kg) combined with XELOX (oxaliplatin 130 mg/m2, IV, qd + capecitabine 1000 mg/m2, bid, d1 - d14, q21d) for 2-4 courses
| Study group | Role | What they receive |
|---|---|---|
| the feasibility of neoadjuvant treatment of locally advanced rectal adenocarcinoma with sintilimab c | Experimental | Sintilimab (3 mg/kg, IV, qd for patients with body weight < 60 kg; 200 mg, IV, qd for patients with body weight ≥ 60 kg) combined with XELOX (oxaliplatin 130 mg/m2, IV, qd + capecitabine 1000 mg/m2, bid, d1 - d14, q21d) for 2-4 courses Receives: Biological: Sintilimab combined with XELOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
An exploratory, phase II clinical study on the feasibility of neoadjuvant treatment of locally advanced rectal adenocarcinoma with sintilimab combined with chemotherapy
Objective response rate refers to the proportion of patients who achieve complete response (CR) and partial response (PR) among the treated patients within a certain period of time.
Measured: From enrollment to 2-4 courses (about 4-8 weeks) of adjuvant therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start1 Jun 2022
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pathological Complete ResponseStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07127497
- Sponsor's protocol ID
- PJ 2025-07-31
- Status last verified
- Mar 2025
- First submitted
- 11 Aug 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Evaluation of Neoadjuvant Chemotherapy Without Radiotherapy Combined With Sintilimab for Locally Advanced Rectal Cancer: Short-term Results of a Single-arm Phase 2 Trial
- ClinicalTrials.gov ID
- NCT07127497
- Acronym / sponsor ID
- PJ 2025-07-31
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Anhui Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 17 Aug 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 designed as a single-center, phase II exploratory clinical trial to evaluate the pathological response rate and safety of sintilimab (PD-1 inhibitor) combined with XELOX regimen (oxaliplatin + capecitabine) for neoadjuvant treatment of LARC. The study focuses on the pMMR/MSS patient population and attempts to provide a new treatment option for patients who cannot tolerate radiotherapy or need to preserve organ function.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| the feasibility of neoadjuvant treatment of locally advanced rectal adenocarcinoma with sintilimab c | Experimental | Biological: Sintilimab combined with XELOXSintilimab (3 mg/kg, IV, qd for patients with body weight < 60 kg; 200 mg, IV, qd for patients with body weight ≥ 60 kg) combined with XELOX (oxaliplatin 130 mg/m2, IV, qd + capecitabine 1000 mg/m2, bid, d1 - d14, q21d) for 2-4 courses |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Sintilimab combined with XELOXSintilimab (3 mg/kg, IV, qd for patients with body weight < 60 kg; 200 mg, IV, qd for patients with body weight ≥ 60 kg) combined with XELOX (oxaliplatin 130 mg/m2, IV, qd + capecitabine 1000 mg/m2, bid, d1 - d14, q21d) for 2-4 courses | Biological | the feasibility of neoadjuvant treatment of locally advanced rectal adenocarcinoma with sintilimab c |
Primary outcome
An exploratory, phase II clinical study on the feasibility of neoadjuvant treatment of locally advanced rectal adenocarcinoma with sintilimab combined with chemotherapy
Time frame: From enrollment to 2-4 courses (about 4-8 weeks) of adjuvant therapy
Objective response rate refers to the proportion of patients who achieve complete response (CR) and partial response (PR) among the treated patients within a certain period of time.
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 21 Nov 2025.
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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 Sintilimab combined with XELOX in people with Pathological Complete Response and Rectal Cancer, run by The First Affiliated Hospital of Anhui 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?
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 21 Nov 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?
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?
An exploratory, phase II clinical study on the feasibility of neoadjuvant treatment of locally advanced rectal adenocarcinoma with sintilimab combined with chemotherapy (time frame: From enrollment to 2-4 courses (about 4-8 weeks) of adjuvant therapy). 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 21 Nov 2025.