Multiple CancerPhase 2NCT06002789
Safety and Efficacy of PD-1 ± mFOLFOX6 Neoadjuvant Therapy in Local Advanced sMPCC
A Phase 2 study testing MSI-H/MSS (dMMR/pMMR) mixed sMPCC: combination of mFOLFOX6+PD-1 monoclonal antibody neoadjuvant therapy and All-MSI-H (dMMR) sMPCC: single-drug PD-1 monoclonal antibody neoadjuvant therapy in people with Multiple Cancer and Colorectal Cancer, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial summary
At present, radical resection ± preoperative neoadjuvant chemotherapy for colorectal cancer is still the standard comprehensive treatment. In recent years, immunotherapy of PD-1 monoclonal antibody has a significant effect in the second-line/first-line treatment of dMMR/MSI-H advanced colorectal cancer and the… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Multiple Cancer, Colorectal Cancer
- What is being tested?
- MSI-H/MSS (dMMR/pMMR) mixed sMPCC: combination of mFOLFOX6+PD-1 monoclonal antibody neoadjuvant therapy and All-MSI-H (dMMR) sMPCC: single-drug PD-1 monoclonal antibody neoadjuvant therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2022to 1 Dec 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological confirmation of simultaneous multiple primary colorectal cancer (sMPCC);
- Tumor biopsy immunohistochemistry of at least one tumor lesion identified dMMR, including the expression loss of one or more of the four proteins MSH1, MSH2, MSH6 and PMS2; or at least one tumor lesion identified MSI-H by polymerase chain reaction or next-generation sequencing technique;
- Clinical staging T3-4NxM0, with or without positive MRF, with or without positive EMVI;
- Staging method: all patients undergo chest,abdominal and pelvic enhanced CT, rectal palpation, high resolution MRI examination，positive perienteric lymph node(LN): short diameter ≥10mm LN or LN with typical metastatic shape and MRI character, clinical data should be re-evaluated and judged by center evaluation group when there are contradictory stagings，distant metastasis were excluded by chest and abdominal enhanced CT and pelvic enhanced MRI;
- No intestinal obstruction symptom，or obstruction relieved after proximal colostomy;
- No colorectal surgery history;
Show all 10Show fewer
- No chemotherapy or radiotherapy history;
- No biopharmaceutical treatment history(such as monoclonal antibody), immunotherapy(such as anti PD-1antibody, anti PD-L1 antibody, anti PD-L2 antibody or anti CTLA-4), or other research drug treatment;
- No endocrinotherapy history restriction;
- informed consent assigned.
Who cannot join
- Arrhythmia need anti-arrhythmia treatment(except β-blocking agent or Digoxin), symptomatic coronary heart disease or myocardial ischemia(myocardial infarction within 6 months) or congestive heart-failure (CHF) > NYHA grade II;
- Severe hypertension not well controlled by drugs;
- HIV infection history or active phase of chronic Hepatitis B or C(high copies of virus DNA);
- Active tuberculosis(TB), accepting anti-TB treatment or anti-TB treatment within 1 year before trial screen;
- Other active clinical severe infection(NCI-CTC AE V5.0);
- Outside pelvic distant metastasis evidences;
Show all 18Show fewer
- Dyscrasia, organ dysfunction;
- Pelvic or abdominal radiotherapy history;
- Epilepsy need treatments(Steroid or anti-epilepsy therapy);
- Other malignant tumor history within 5 years;
- Over abuse of drugs, medical and psychological or social conditions that might interfere patients or evaluation of the study results;
- Any active autoimmune disease or autoimmune disease history (including but not restricted: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism, hypothyroidism, asthma need bronchodilators);
- Any anti-infection vaccine injection 4 weeks before inclusion;
- Long-term exposure to immune-suppressor, combination of systemic or topical use of corticosteroids (dose>10mg/day prednisolone or equivalent hormone);
- Known or suspicious allergy to any study related drugs;
- Any unstable state might cause damage to the safety and compliance of patients;
- Pregnant or breast feeding women who has ability to have children while without contraception;
- Refuse to sign informed consent.
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
The Sixth Affiliated Hospital, Sun Yatsen University
Guangzhou, Guangdong
Jun Huang, MD, 13926451242, huangj97@mail.sysu.edu.cn
About this study
Official title: Safety and Efficacy of PD-1 Monoclonal Antibody With or Without mFOLFOX6 Neoadjuvant Therapy in Patients With Local Advanced Deficient Mismatch Repair/Microsatellite Instability-high Synchronous Multiple Primary Colorectal Cancer (sMPCC)
At present, radical resection ± preoperative neoadjuvant chemotherapy for colorectal cancer is still the standard comprehensive treatment. In recent years, immunotherapy of PD-1 monoclonal antibody has a significant effect in the second-line/first-line treatment of dMMR/MSI-H advanced colorectal cancer and the neoadjuvant treatment of early colorectal cancer. Synchronous multiple primary colorectal cancer (sMPCC) is a relatively rare type of colorectal cancer (CRC) that refers to the simultaneous occurrence of 2 or more independent primary malignancies in the colon or rectum. The recent large-scale, single-center retrospective study of the investigator showed that compared with single primary colorectal cancer (SPCRC)patients, the incidence of dMMR/MSI-H was significantly higher in sMPCC patients. Besides, a certain proportion of sMPCC patients could both have MSI and MSS tumors at the same time. There is no standard regimen for this patients so far. This study intends to treat the MSI-H/MSS (dMMR/pMMR) mixed sMPCC patients with combination of mFOLFOX6+PD-1 monoclonal antibody neoadjuvant therapy, and treat the all-MSI-H (dMMR) sMPCC patients with single-drug PD-1 monoclonal antibody neoadjuvant therapy. Given the current gaps in the guideline, the investigator intends to take the lead in carrying out this open, multi-center, prospective clinical phase II study. This study might provide a clinical evidence for individual treatment of sMPCC patients, in preserving the functions and organs to the greatest extent.
Read the detailed description
Colorectal cancer is one of the most common malignant tumors in the world. At present, radical resection ± preoperative neoadjuvant chemotherapy for colorectal cancer is still the standard comprehensive treatment recommended by the two major international guidelines of NCCN and ESMO, as well as the Chinese CSCO guidelines. Mismatch repair protein (MMR) expression and microsatellite instability (MSI) status are important factors affecting the efficacy of immunotherapy. In recent years, immunotherapy of PD-1 monoclonal antibody has a significant effect in the second-line/first-line treatment of dMMR/MSI-H advanced colorectal cancer and the neoadjuvant treatment of early colorectal cancer, all of which have shown very good efficacy with great safety and tolerable toxicity.
Synchronous multiple primary colorectal cancer (sMPCC) is a relatively rare type of colorectal cancer (CRC) that refers to the simultaneous occurrence of 2 or more independent primary malignancies in the colon or rectum of the same patient. Since 2000, the annual incidence and mortality of CRC in China have continued to increase, and the incidence of sMPCC has also increased. The overall incidence of sMPCC ranges from 1.1% to 8.1% of CRC patients. The recent large-scale, single-center retrospective study of the investigator showed that among 239 sMPCC patients, the proportions of all-pMMR, all-dMMR, and mixed types (pMMR/dMMR) were 189 (79.1%), 40 (16.7%), and 10 (4.2%), respectively. Compared with single primary colorectal cancer (SPCRC) patients, the incidence of dMMR was significantly higher in sMPCC patients (50/239 vs 872/13037). The results of NGS detection of MSI status were consistent with the results of Immunohistochemistry (IHC), 21.8% (17/78) of sMPCC patients were MSI-H, while the proportion was only 5.3% (5/94) in SPCRC patients. At present, single-drug PD-1 or combined with other immunotherapy has become the first-line treatment for MSI-H SPCRC patients. However, there is no standard regimen for some sMPCC patients who both have MSI-H and MSS lesions. Moreover, there are no studies and reports on the treatment of mFOLFOX6+PD-1 monoclonal antibody in MSI-H/MSS mixed sMPCC and PD-1 monoclonal antibody in all-MSI-H sMPCC.
This study intends to treat the MSI-H/MSS (dMMR/pMMR) mixed sMPCC patients with combination of mFOLFOX6+PD-1 monoclonal antibody neoadjuvant therapy, and treat the all-MSI-H (dMMR) sMPCC patients with single-drug PD-1 monoclonal antibody neoadjuvant therapy. As one of the largest single centers for the diagnosis and treatment of colorectal cancer in China, the Sixth Affiliated Hospital of Sun Yat-sen University has performed nearly 4,000 cases of colorectal cancer surgery per year. Therefore, the investigator intends to take the lead in carrying out this open, multi-center, prospective clinical phase II study in the world. The investigator will give different treatments by the result of microsatellite instability status of all lesions in sMPCC. The pCR rate, incidence of AEs of neoadjuvant therapy, R0 resection rate, down-stage rate, 3 years DFS rate and OS rate are analyzed. This study might provide a clinical evidence for individual treatment of sMPCC patients, in preserving the functions and organs to the greatest extent.
- Conditions
- Multiple Cancer, Colorectal Cancer
- Being tested
- MSI-H/MSS (dMMR/pMMR) mixed sMPCC: combination of mFOLFOX6+PD-1 monoclonal antibody neoadjuvant therapy, All-MSI-H (dMMR) sMPCC: single-drug PD-1 monoclonal antibody neoadjuvant therapy
- Keywords
- Synchronous multiple primary colorectal cancer, PD-1, Neoadjuvant treatment, MSI-H
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSI-H/MSS (dMMR/pMMR) mixed sMPCC: combination of mFOLFOX6+PD-1 monoclonal antibody neoadjuvant therapyDrug
Also called Mixed sMPCC
For MSI-H/MSS (dMMR/pMMR) mixed sMPCC, a combination of neoadjuvant chemotherapy with mFOLFOX6 and immunotherapy with PD-1 monoclonal antibody are applied.
All-MSI-H (dMMR) sMPCC: single-drug PD-1 monoclonal antibody neoadjuvant therapyDrug
Also called MSI-H sMPCC
For all-MSI-H (dMMR) sMPCC, single-drug PD-1 monoclonal antibody immunotherapy is applied.
| Study group | Role | What they receive |
|---|---|---|
| MSI-H/MSS (dMMR/pMMR) mixed sMPCC or all-MSI-H (dMMR) sMPCC | Experimental | 1. MSI-H/MSS (dMMR/pMMR) mixed sMPCC: Synchronous multiple primary colorectal cancer consist of MSI/dMMR and MSS/pMMR tumors at the same time
2. all-MSI-H (dMMR) sMPCC: Synchronous multiple primary colorectal cancer with all MSI/dMMR tumors Receives: Drug: MSI-H/MSS (dMMR/pMMR) mixed sMPCC: combination of mFOLFOX6+PD-1 monoclonal antibody neoadjuvant therapy; Drug: All-MSI-H (dMMR) sMPCC: single-drug PD-1 monoclonal antibody neoadjuvant therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
pCR rate
pathological complete remission rate
Measured: 1 year
Secondary outcomes (6)
Incidence rate of Grade ≥3 PD-1monoclonal antibody-related adverse events
Incidence rate of participants with Grade ≥3 PD-1monoclonal antibody-related adverse events as assessed by CTCAE v4.0
Measured: 1 year
Incidence rate of Grade ≥3 chemotherapy-related adverse events
Incidence rate of participants with Grade ≥3 chemotherapy-related adverse adverse events as assessed by CTCAE v4.0
Measured: 1 year
R0 resection rate
R0 resection rate in participants treated after mFOLFOX6+Bevacizumab+PD-1monoclonal antibody
Measured: 1 year
Down-stage rate
Down-stage rate of pathological stage after surgery compared with clinical stage before drug treatment
Measured: 1 year
3 years DFS Rate
3 years Disease Free Survival Rate
Measured: 3 years
3 years OS Rate
3 years Overall Survival Rate
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start1 May 2022
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple CancerStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, 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
- MSI-H/MSS (dMMR/pMMR) mixed sMPCC or all-MSI-H (dMMR) sMPCC
- Masking
- None (open label)
- Enrolment
- 17 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06002789
- Sponsor's protocol ID
- E2023073
- Status last verified
- Feb 2026
- First submitted
- 16 Aug 2023
- Last updated
- 27 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of PD-1 Monoclonal Antibody With or Without mFOLFOX6 Neoadjuvant Therapy in Patients With Local Advanced Deficient Mismatch Repair/Microsatellite Instability-high Synchronous Multiple Primary Colorectal Cancer (sMPCC)
- ClinicalTrials.gov ID
- NCT06002789
- Acronym / sponsor ID
- E2023073
- Conditions
- Multiple Cancer, Colorectal Cancer
- Keywords
- Synchronous multiple primary colorectal cancer, PD-1, Neoadjuvant treatment, MSI-H
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 21 Aug 2023 (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.
At present, radical resection ± preoperative neoadjuvant chemotherapy for colorectal cancer is still the standard comprehensive treatment. In recent years, immunotherapy of PD-1 monoclonal antibody has a significant effect in the second-line/first-line treatment of dMMR/MSI-H advanced colorectal cancer and the neoadjuvant treatment of early colorectal cancer. Synchronous multiple primary colorectal cancer (sMPCC) is a relatively rare type of colorectal cancer (CRC) that refers to the simultaneous occurrence of 2 or more independent primary malignancies in the colon or rectum. The recent large-scale, single-center retrospective study of the investigator showed that compared with single primary colorectal cancer (SPCRC)patients, the incidence of dMMR/MSI-H was significantly higher in sMPCC patients. Besides, a certain proportion of sMPCC patients could both have MSI and MSS tumors at the same time. There is no standard regimen for this patients so far. This study intends to treat the MSI-H/MSS (dMMR/pMMR) mixed sMPCC patients with combination of mFOLFOX6+PD-1 monoclonal antibody neoadjuvant therapy, and treat the all-MSI-H (dMMR) sMPCC patients with single-drug PD-1 monoclonal antibody neoadjuvant therapy. Given the current gaps in the guideline, the investigator intends to take the lead in carrying out this open, multi-center, prospective clinical phase II study. This study might provide a clinical evidence for individual treatment of sMPCC patients, in preserving the functions and organs to the greatest extent.
Detailed description
Colorectal cancer is one of the most common malignant tumors in the world. At present, radical resection ± preoperative neoadjuvant chemotherapy for colorectal cancer is still the standard comprehensive treatment recommended by the two major international guidelines of NCCN and ESMO, as well as the Chinese CSCO guidelines. Mismatch repair protein (MMR) expression and microsatellite instability (MSI) status are important factors affecting the efficacy of immunotherapy. In recent years, immunotherapy of PD-1 monoclonal antibody has a significant effect in the second-line/first-line treatment of dMMR/MSI-H advanced colorectal cancer and the neoadjuvant treatment of early colorectal cancer, all of which have shown very good efficacy with great safety and tolerable toxicity.
Synchronous multiple primary colorectal cancer (sMPCC) is a relatively rare type of colorectal cancer (CRC) that refers to the simultaneous occurrence of 2 or more independent primary malignancies in the colon or rectum of the same patient. Since 2000, the annual incidence and mortality of CRC in China have continued to increase, and the incidence of sMPCC has also increased. The overall incidence of sMPCC ranges from 1.1% to 8.1% of CRC patients. The recent large-scale, single-center retrospective study of the investigator showed that among 239 sMPCC patients, the proportions of all-pMMR, all-dMMR, and mixed types (pMMR/dMMR) were 189 (79.1%), 40 (16.7%), and 10 (4.2%), respectively. Compared with single primary colorectal cancer (SPCRC) patients, the incidence of dMMR was significantly higher in sMPCC patients (50/239 vs 872/13037). The results of NGS detection of MSI status were consistent with the results of Immunohistochemistry (IHC), 21.8% (17/78) of sMPCC patients were MSI-H, while the proportion was only 5.3% (5/94) in SPCRC patients. At present, single-drug PD-1 or combined with other immunotherapy has become the first-line treatment for MSI-H SPCRC patients. However, there is no standard regimen for some sMPCC patients who both have MSI-H and MSS lesions. Moreover, there are no studies and reports on the treatment of mFOLFOX6+PD-1 monoclonal antibody in MSI-H/MSS mixed sMPCC and PD-1 monoclonal antibody in all-MSI-H sMPCC.
This study intends to treat the MSI-H/MSS (dMMR/pMMR) mixed sMPCC patients with combination of mFOLFOX6+PD-1 monoclonal antibody neoadjuvant therapy, and treat the all-MSI-H (dMMR) sMPCC patients with single-drug PD-1 monoclonal antibody neoadjuvant therapy. As one of the largest single centers for the diagnosis and treatment of colorectal cancer in China, the Sixth Affiliated Hospital of Sun Yat-sen University has performed nearly 4,000 cases of colorectal cancer surgery per year. Therefore, the investigator intends to take the lead in carrying out this open, multi-center, prospective clinical phase II study in the world. The investigator will give different treatments by the result of microsatellite instability status of all lesions in sMPCC. The pCR rate, incidence of AEs of neoadjuvant therapy, R0 resection rate, down-stage rate, 3 years DFS rate and OS rate are analyzed. This study might provide a clinical evidence for individual treatment of sMPCC patients, in preserving the functions and organs to the greatest extent.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- MSI-H/MSS (dMMR/pMMR) mixed sMPCC or all-MSI-H (dMMR) sMPCC
| Arm | Type | Receives |
|---|---|---|
| MSI-H/MSS (dMMR/pMMR) mixed sMPCC or all-MSI-H (dMMR) sMPCC | Experimental | Drug: MSI-H/MSS (dMMR/pMMR) mixed sMPCC: combination of mFOLFOX6+PD-1 monoclonal antibody neoadjuvant therapy, Drug: All-MSI-H (dMMR) sMPCC: single-drug PD-1 monoclonal antibody neoadjuvant therapy1. MSI-H/MSS (dMMR/pMMR) mixed sMPCC: Synchronous multiple primary colorectal cancer consist of MSI/dMMR and MSS/pMMR tumors at the same time 2. all-MSI-H (dMMR) sMPCC: Synchronous multiple primary colorectal cancer with all MSI/dMMR tumors |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histological confirmation of simultaneous multiple primary colorectal cancer (sMPCC);
- Tumor biopsy immunohistochemistry of at least one tumor lesion identified dMMR, including the expression loss of one or more of the four proteins MSH1, MSH2, MSH6 and PMS2; or at least one tumor lesion identified MSI-H by polymerase chain reaction or next-generation sequencing technique;
- Clinical staging T3-4NxM0, with or without positive MRF, with or without positive EMVI;
- Staging method: all patients undergo chest,abdominal and pelvic enhanced CT, rectal palpation, high resolution MRI examination，positive perienteric lymph node(LN): short diameter ≥10mm LN or LN with typical metastatic shape and MRI character, clinical data should be re-evaluated and judged by center evaluation group when there are contradictory stagings，distant metastasis were excluded by chest and abdominal enhanced CT and pelvic enhanced MRI;
- No intestinal obstruction symptom，or obstruction relieved after proximal colostomy;
Key exclusion criteria (18 listed)
- Arrhythmia need anti-arrhythmia treatment(except β-blocking agent or Digoxin), symptomatic coronary heart disease or myocardial ischemia(myocardial infarction within 6 months) or congestive heart-failure (CHF) > NYHA grade II;
- Severe hypertension not well controlled by drugs;
- HIV infection history or active phase of chronic Hepatitis B or C(high copies of virus DNA);
- Active tuberculosis(TB), accepting anti-TB treatment or anti-TB treatment within 1 year before trial screen;
- Other active clinical severe infection(NCI-CTC AE V5.0);
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 |
|---|---|---|
| MSI-H/MSS (dMMR/pMMR) mixed sMPCC: combination of mFOLFOX6+PD-1 monoclonal antibody neoadjuvant therapyAlso: Mixed sMPCCFor MSI-H/MSS (dMMR/pMMR) mixed sMPCC, a combination of neoadjuvant chemotherapy with mFOLFOX6 and immunotherapy with PD-1 monoclonal antibody are applied. | Drug | MSI-H/MSS (dMMR/pMMR) mixed sMPCC or all-MSI-H (dMMR) sMPCC |
| All-MSI-H (dMMR) sMPCC: single-drug PD-1 monoclonal antibody neoadjuvant therapyAlso: MSI-H sMPCCFor all-MSI-H (dMMR) sMPCC, single-drug PD-1 monoclonal antibody immunotherapy is applied. | Drug | MSI-H/MSS (dMMR/pMMR) mixed sMPCC or all-MSI-H (dMMR) sMPCC |
Primary outcome
pCR rate
Time frame: 1 year
pathological complete remission rate
6 secondary outcomes
Incidence rate of Grade ≥3 PD-1monoclonal antibody-related adverse events
Time frame: 1 year
Incidence rate of Grade ≥3 chemotherapy-related adverse events
Time frame: 1 year
R0 resection rate
Time frame: 1 year
Down-stage rate
Time frame: 1 year
3 years DFS Rate
Time frame: 3 years
3 years OS Rate
Time frame: 3 years
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 27 Apr 2026.
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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.
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 MSI-H/MSS (dMMR/pMMR) mixed sMPCC: combination of mFOLFOX6+PD-1 monoclonal antibody neoadjuvant therapy and All-MSI-H (dMMR) sMPCC: single-drug PD-1 monoclonal antibody neoadjuvant therapy in people with Multiple Cancer and Colorectal Cancer, run by Sixth Affiliated Hospital, 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 10 inclusion and 18 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 27 Apr 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?
Contact Jun Huang, MD (13926451242, huangj97@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pCR rate (time frame: 1 year). 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 27 Apr 2026.