Colorectal NeoplasmsNCT05368051
Multi-omics Model Predicts Efficacy of Preoperative Neoadjuvant Chemoradiotherapy Combined PD-1 Antibody Therapy for Locally Advanced Rectal Cancer
An observational study of Colorectal Neoplasms, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
The purpose of this clinical research is to establish a multi-omics model based on genomics，transcriptomics，gut microbiota in predicting pathologic response after neoadjuvant chemoradiotherapy combined PD-1 antibody given to patients with locally advanced rectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- long course radiotherapy + capecitabine + PD-1 monoclonal antibody
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2021to 31 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Mid to low LARC
Who may be able to join
- Patients have been fully aware of the content of this study and signed the informed consent voluntarily;
- Patients with rectal cancers must satisfied all the following conditions: Stage II/III LARC (cT1-3N1-2M0)；Tumor distal location ≤ 7 cm from anal verge (MRI diagnosed);
- Patients regardless of gender with aged ≥18 years and ECOG score of 0 or 1;
- Physical and viscera function of patients can withstand major abdominal surgery;
- Patients are willing and able to follow the study protocol during the study;
- Patients give consent to the use of blood and pathological specimens for study;
- Within 28 days prior to enrolment, we must confirm a negative serological pregnancy test for child-bearing age women and they agree to use effective contraception for the duration of drug use and for 60 days after the last dose.
Who cannot join
- Patients have a present or previous active malignancy except the diagnosis of rectal cancer this time;
- Patients underwent major surgery within 4 weeks prior to study treatment;
- Patients have any condition affects the absorption of capecitabine through gastrointestinal tract;
- Patients have severe uncontrolled recurrent infections, or other severe uncontrolled concomitant diseases;
- Patients who are allergic to any of the ingredients under study;
- Patients with severe concomitant diseases with estimated survival ≤ 5 years;
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- Patients with present or previous moderate or severe liver and kidney damage presently or previously;
- Patients have received other study medications or any immunotherapy currently or in the past;
- Patients preparing for or previously received organ or bone marrow transplant;
- Patients who received immunosuppressive or systemic hormone therapy for immunosuppressive purposes within 1 month prior to the initiation of study therapy;
- Patients with congenital or acquired immune deficiency (such as HIV infection);
- If patients with a history of uncontrolled epilepsy, central nervous system disease or mental disorder, the investigator will determine whether the clinical severity prevents the signing of informed consent or affects the patient's oral medication compliance;
- Patients with other factors that may affect the study results or cause the study to be terminated midway, such as alcoholism, drug abuse, other serious diseases (including mental illness) requiring combined treatment and severe laboratory examination abnormalities.
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Friendship Hospital
Beijing, Beijing Municipality, 100050
Hongwei Yao, Dr, +8613611015609 ext. 63139203, yaohongwei@medmail.com.cn
About this study
The purpose of this clinical research is to establish a multi-omics model based on genomics，transcriptomics，gut microbiota in predicting pathologic response after neoadjuvant chemoradiotherapy combined PD-1 antibody given to patients with locally advanced rectal cancer.
- Conditions
- Colorectal Neoplasms
- Being tested
- long course radiotherapy + capecitabine + PD-1 monoclonal 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.
long course radiotherapy + capecitabine + PD-1 monoclonal antibodyCombination product
long course radiotherapy + capecitabine + PD-1 monoclonal antibody treatment combinations in patients with locally advanced rectal cancer
| Study group | Role | What they receive |
|---|---|---|
| long course radiotherapy + capecitabine + PD-1 monoclonal antibody | long course radiotherapy + capecitabine + PD-1 monoclonal antibody treatment combinations in patients with locally advanced rectal cancer Receives: Combination Product: long course radiotherapy + capecitabine + PD-1 monoclonal antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathologic complete response（pCR）
All the enrolled patients will receive total mesorectal excision (TME) 7-9 weeks after the end of long course radiotherapy. The rectal specimens will be evaluated by the pathologists who are experienced on the rectal cancer diagnosis according to the 1997 Dworak grading system. The rectal cancer will be classified into 5 grades. Grade 0-3 will be considered as non-pCR while grade 4 represent pCR.
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 posted10 May 2022
- Study start1 Oct 2021
- Primary completion31 Oct 2022 (estimated)
- Study completion31 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Beijing Friendship 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhongtao Zhang, Beijing Friendship Hospital
- Investigators
- Hongwei Yao, Dr, Study director, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05368051
- Sponsor's protocol ID
- BFH-MMCRP
- Status last verified
- May 2022
- First submitted
- 5 May 2022
- Last updated
- 10 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ma J, Sun S, Cheng X, Meng C, Zhao H, Fu W, Gao Y, Ma L, Yang Z, Yao H, Su J. Unraveling the role of gut microbiome in predicting adverse events in neoadjuvant therapy for rectal cancer. Hum Vaccin Immunother. 2024 Dec 31;20(1):2430087. doi: 10.1080/21645515.2024.2430087. Epub 2024 Dec 2.
PubMed 39623529Yang Z, Ma J, Han J, Li A, Liu G, Sun Y, Zheng J, Zhang J, Chen G, Xu R, Sun L, Meng C, Gao J, Bai Z, Deng W, Zhang C, Su J, Yao H, Zhang Z. Gut microbiome model predicts response to neoadjuvant immunotherapy plus chemoradiotherapy in rectal cancer. Med. 2024 Oct 11;5(10):1293-1306.e4. doi: 10.1016/j.medj.2024.07.002. Epub 2024 Jul 23.
PubMed 39047732
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-omics Model Predicts Efficacy of Preoperative Neoadjuvant Chemoradiotherapy Combined PD-1 Antibody Therapy for Locally Advanced Rectal Cancer
- ClinicalTrials.gov ID
- NCT05368051
- Acronym / sponsor ID
- BFH-MMCRP
- Conditions
- Colorectal Neoplasms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 31 Oct 2022 (estimated)
- Study completion
- 31 Oct 2022 (estimated)
- First posted
- 10 May 2022 (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.
The purpose of this clinical research is to establish a multi-omics model based on genomics，transcriptomics，gut microbiota in predicting pathologic response after neoadjuvant chemoradiotherapy combined PD-1 antibody given to patients with locally advanced rectal cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| long course radiotherapy + capecitabine + PD-1 monoclonal antibody | – | Combination Product: long course radiotherapy + capecitabine + PD-1 monoclonal antibodylong course radiotherapy + capecitabine + PD-1 monoclonal antibody treatment combinations in patients with locally advanced rectal cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Mid to low LARC
Key inclusion criteria (7 listed)
- Patients have been fully aware of the content of this study and signed the informed consent voluntarily;
- Patients with rectal cancers must satisfied all the following conditions: Stage II/III LARC (cT1-3N1-2M0)；Tumor distal location ≤ 7 cm from anal verge (MRI diagnosed);
- Patients regardless of gender with aged ≥18 years and ECOG score of 0 or 1;
- Physical and viscera function of patients can withstand major abdominal surgery;
- Patients are willing and able to follow the study protocol during the study;
Key exclusion criteria (14 listed)
- Patients have a present or previous active malignancy except the diagnosis of rectal cancer this time;
- Patients underwent major surgery within 4 weeks prior to study treatment;
- Patients have any condition affects the absorption of capecitabine through gastrointestinal tract;
- Patients have severe uncontrolled recurrent infections, or other severe uncontrolled concomitant diseases;
- Patients who are allergic to any of the ingredients under study;
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 radiotherapy + capecitabine + PD-1 monoclonal antibodylong course radiotherapy + capecitabine + PD-1 monoclonal antibody treatment combinations in patients with locally advanced rectal cancer | Combination product | long course radiotherapy + capecitabine + PD-1 monoclonal antibody |
Primary outcome
pathologic complete response（pCR）
Time frame: 1 year
All the enrolled patients will receive total mesorectal excision (TME) 7-9 weeks after the end of long course radiotherapy. The rectal specimens will be evaluated by the pathologists who are experienced on the rectal cancer diagnosis according to the 1997 Dworak grading system. The rectal cancer will be classified into 5 grades. Grade 0-3 will be considered as non-pCR while grade 4 represent pCR.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
- Derived from this study: PubMed 39623529Ma J, Sun S, Cheng X, Meng C, Zhao H, Fu W, Gao Y, Ma L, Yang Z, Yao H, Su J. Unraveling the role of gut microbiome in predicting adverse events in neoadjuvant therapy for rectal cancer. Hum Vaccin Immunother. 2024 Dec 31;20(1):2430087. doi: 10.1080/21645515.2024.2430087. Epub 2024 Dec 2.
- Derived from this study: PubMed 39047732Yang Z, Ma J, Han J, Li A, Liu G, Sun Y, Zheng J, Zhang J, Chen G, Xu R, Sun L, Meng C, Gao J, Bai Z, Deng W, Zhang C, Su J, Yao H, Zhang Z. Gut microbiome model predicts response to neoadjuvant immunotherapy plus chemoradiotherapy in rectal cancer. Med. 2024 Oct 11;5(10):1293-1306.e4. doi: 10.1016/j.medj.2024.07.002. Epub 2024 Jul 23.
- Individual participant dataSharing planned: Undecided
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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.
Hongwei Yao, Dr study director
Beijing Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Neoplasms, run by Beijing Friendship 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 7 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: status not confirmed, as of the sponsor's last update on 10 May 2022. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hongwei Yao, Dr (+8613611015609 ext. 63139203, yaohongwei@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pathologic complete response（pCR） (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 NCT05368051, which also lists 2 linked publications.
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 10 May 2022.