Colorectal CarcinomaPhase 2NCT04833387
PD-1 Antibody Following Preoperative Chemoradiotherapy for Locally Advanced pMMR/MSS Rectal Cancer
A Phase 2 study testing PD-1 antibody in people with Colorectal Carcinoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
In this open-label phase II study, patients will be scheduled for neoadjuvant treatment with PD-1 antibody following preoperative Chemoradiotherapy with capecitabine for pMMR/MSS rectal cancer staged as locally advanced (cT3-T4N+/-M0 for rectal cancer). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Carcinoma
- What is being tested?
- PD-1 antibody
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 Dec 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who personally provided written consent for participation in the study
- Treatment-naive patients with rectal cancer, in whom the inferior margin of the tumor was at a distance of 12 cm or less from the AV before CRT
- Primary rectal cancer histopathologically confirmed to be adenocarcinoma
- Clinical stage of T3,and T4 ,N any,M0,before CRT
- Macroscopic radical resection could be feasible, based on diagnostic imaging before CRT
- Patients with the ECOG performance status of 0 or 1 at the time of enrollment
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- Patients without distant metastasis on the imaging test before CRT
- Preoperative biopsy of tumor immunohistochemistry TPS>1% or CPS>1
- Life expectancy of greater than 2 years
- No signs of intestinal obstruction; or the obstruction has been relieved after the proximal colostomy operation
- Hematology: WBC>4000/mm3; PLT>100000/mm3; Hb>10g/dL
- Liver function: SGOT and SGPT are less than 1.5 times the normal value; bilirubin is less than 1.5mg/dL
- Renal function: creatinine <1.8mg/dL Others: non-pregnant or breast-feeding women; no other malignant diseases (except for non-melanoma or cervical carcinoma in situ) within 5 years or during the same period; no mental illness that causes the inability to obtain informed consent; no other serious diseases that can shorten the survival time disease.
- Have not received rectal surgery in the past;
- Have not received chemotherapy or radiotherapy in the past;
- Have not received biological treatment in the past;
- Past endocrine therapy: unlimited.
Who cannot join
- Rectal cancer with unstable microsatellite (MSI or dMMR);
- Preoperative biopsy of tumor immunohistochemistry TPS≤1% or CPS≤1
- Known history of human immunodeficiency virus (HIV) or chronic hepatitis B or C (high copy viral DNA);
- Autoimmune diseases;
- Other active clinical serious infections (>NCI-CTC version 3.0);
- Patients in clinical phase I;
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- There is evidence that there is distant metastasis before surgery;
- Cachexia, decompensation of organ function;
- Have a history of pelvic or abdominal radiotherapy;
- Multiple primary cancers;
- Patients who need treatment for seizures (such as steroids or anti-epileptic treatment);
- Have a known additional malignant tumors within 5 years. Exceptions include basal cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer;
- Chronic inflammatory bowel disease, intestinal obstruction;
- Drug abuse and medical, psychological or social conditions may interfere with patients' participation in research or have an impact on the evaluation of research results;
- Known or suspected to be allergic to the study drug or to any drug given in connection with this test;
- Any unstable conditions or situations that may endanger patient safety and compliance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PD-1 Antibody as a Sequential Therapy Following Preoperative Chemoradiotherapy for Locally Advanced pMMR/MSS Rectal Cancer: an Open, Multi-center, Phase II Clinical Trial
In this open-label phase II study, patients will be scheduled for neoadjuvant treatment with PD-1 antibody following preoperative Chemoradiotherapy with capecitabine for pMMR/MSS rectal cancer staged as locally advanced (cT3-T4N+/-M0 for rectal cancer). This treatment will be given during the window period until surgical resection of the tumor.
- Conditions
- Colorectal Carcinoma
- Being tested
- PD-1 antibody
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-1 antibodyDrug
Capecitabine:Dose of 1650mg/m2,14days; Radiation:50Gy/25 fractions;IBI308: 200mg on day1 of each cycle, 3 cycles; Surgical therapy:The resection (LAR), intersphincteric resection (ISR), or abdominoperineal resection (APR)
| Study group | Role | What they receive |
|---|---|---|
| PD-1 antibody + capecitabine + radiation | Experimental | Not described Receives: Drug: PD-1 antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response
Pathological complete response will be evaluated with American Joint Committee on Cancer (AJCC) Cancer Staging
Measured: 1 year
Secondary outcomes (3)
Relapse-free survival (RFS)
Measured: 3 years
Overall survival (OS)
Measured: 3 years
Clinical complete response (CCR)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2021
- Study start1 Jan 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CarcinomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- Model description
- PD-1
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Liaoning Cancer Hospital & Institute, Fudan University
- Responsible party
- Principal investigator, Pei-Rong Ding, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04833387
- Sponsor's protocol ID
- B2019-092
- Status last verified
- Jan 2023
- First submitted
- 4 Apr 2021
- Last updated
- 11 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hou Z, Liao L, Xiao W, Sui Q, Han K, Xiao B, Li Y, Mei W, Yu J, Hong Z, Chen Q, Song R, Li D, Zhang X, Wang Q, Pan Z, Jiang W, Ding P. Neoadjuvant chemoradiotherapy plus sintilimab in pMMR/MSS rectal cancer patients with PD-L1 TPS >/= 1% or CPS >/= 1: an open-label, prospective, phase II study. NPJ Precis Oncol. 2025 Jul 12;9(1):237. doi: 10.1038/s41698-025-01018-0.
PubMed 40652024
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PD-1 Antibody as a Sequential Therapy Following Preoperative Chemoradiotherapy for Locally Advanced pMMR/MSS Rectal Cancer: an Open, Multi-center, Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT04833387
- Acronym / sponsor ID
- B2019-092
- Conditions
- Colorectal Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Liaoning Cancer Hospital & Institute, Fudan University
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Apr 2021 (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 this open-label phase II study, patients will be scheduled for neoadjuvant treatment with PD-1 antibody following preoperative Chemoradiotherapy with capecitabine for pMMR/MSS rectal cancer staged as locally advanced (cT3-T4N+/-M0 for rectal cancer). This treatment will be given during the window period until surgical resection of the tumor.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- PD-1
| Arm | Type | Receives |
|---|---|---|
| PD-1 antibody + capecitabine + radiation | Experimental | Drug: PD-1 antibody |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patients who personally provided written consent for participation in the study
- Treatment-naive patients with rectal cancer, in whom the inferior margin of the tumor was at a distance of 12 cm or less from the AV before CRT
- Primary rectal cancer histopathologically confirmed to be adenocarcinoma
- Clinical stage of T3,and T4 ,N any,M0,before CRT
- Macroscopic radical resection could be feasible, based on diagnostic imaging before CRT
Key exclusion criteria (16 listed)
- Rectal cancer with unstable microsatellite (MSI or dMMR);
- Preoperative biopsy of tumor immunohistochemistry TPS≤1% or CPS≤1
- Known history of human immunodeficiency virus (HIV) or chronic hepatitis B or C (high copy viral DNA);
- Autoimmune diseases;
- Other active clinical serious infections (>NCI-CTC version 3.0);
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 |
|---|---|---|
| PD-1 antibodyCapecitabine:Dose of 1650mg/m2,14days; Radiation:50Gy/25 fractions;IBI308: 200mg on day1 of each cycle, 3 cycles; Surgical therapy:The resection (LAR), intersphincteric resection (ISR), or abdominoperineal resection (APR) | Drug | PD-1 antibody + capecitabine + radiation |
Primary outcome
Pathological complete response
Time frame: 1 year
Pathological complete response will be evaluated with American Joint Committee on Cancer (AJCC) Cancer Staging
3 secondary outcomes
Relapse-free survival (RFS)
Time frame: 3 years
Overall survival (OS)
Time frame: 3 years
Clinical complete response (CCR)
Time frame: 1 year
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 11 Jan 2023.
- Derived from this study: PubMed 40652024Hou Z, Liao L, Xiao W, Sui Q, Han K, Xiao B, Li Y, Mei W, Yu J, Hong Z, Chen Q, Song R, Li D, Zhang X, Wang Q, Pan Z, Jiang W, Ding P. Neoadjuvant chemoradiotherapy plus sintilimab in pMMR/MSS rectal cancer patients with PD-L1 TPS >/= 1% or CPS >/= 1: an open-label, prospective, phase II study. NPJ Precis Oncol. 2025 Jul 12;9(1):237. doi: 10.1038/s41698-025-01018-0.
- 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 PD-1 antibody in people with Colorectal Carcinoma, run by Sun Yat-sen 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 17 inclusion and 16 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 11 Jan 2023. 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?
Pathological complete response (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04833387, which also lists 1 linked publication.
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 11 Jan 2023.