Colon NeoplasmPhase 2ICONICNCT05914389
Induction Chemotherapy Combined With Neoadjuvant Immunotherapy for MSS Colon Cancer
A Phase 2 study testing Oxaliplatin, Capecitabine and Anti-PD-L1 Monoclonal Antibody in people with Colon Neoplasm, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This study aims to elucidate the regression effects of neoadjuvant chemotherapy combined with immunotherapy and adjuvant therapy in locally advanced MSS colon cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colon Neoplasm
- What is being tested?
- Oxaliplatin, Capecitabine and Anti-PD-L1 Monoclonal Antibody
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Aug 2023to Aug 2030
- 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 years old and ≤75 years old.
- Pathologically diagnosed MSS or pMMR-type colon adenocarcinoma.
- The lower edge of the tumor is more than 12cm from the anus as measured by colonoscopy and the lower edge of the tumor cannot be directly palpated during rectal examination.
- Enhanced CT stage T3/4 or T1-4N+ without multiple primary tumors or distant metastasis.
- Life expectancy is expected to be more than 1 year.
- First diagnosis, no previous anti-tumor treatment received, and no chemotherapy contraindications.
- Informed consent, able to understand the study protocol and willing to participate in the study, and will provide written informed consent.
Who cannot join
- Refused to participate in this study.
- Multifocal colorectal cancer.
- History of malignant tumors, except for basal cell carcinoma, papillary thyroid carcinoma, and various in situ cancers.
- Cannot tolerate chemotherapy, such as but not limited to bone marrow suppression.
- Acute exacerbation of important organ diseases (such as but not limited to COPD, coronary heart disease, and renal insufficiency) and/or severe acute infectious diseases (such as but not limited to hepatitis, pneumonia, and myocarditis), ASA score > 3 points.
- Mental disorders, illiteracy, or language communication barriers that prevent the understanding of the study protocol.
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- Tumor obstruction or high risk of obstruction, bleeding, and/or perforation.
- Peripheral sensory neuropathy, unable to receive oxaliplatin-based chemotherapy.
- Pregnancy or lactation.
- Unable to undergo enhanced CT examination or having comorbidities requiring the use of glucocorticoid therapy.
- Continuous use of glucocorticoids for more than 3 days within 1 month prior to signing the informed consent form.
- CT or MRI in the mid-sagittal plane shows that the lower border of the tumor is below the line connecting the sacrococcygeal promontory and the upper border of the pubic symphysis.
- Other situations in which the researcher deems unsuitable for this study.
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
Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Yurong Jiao, +86 13732206364, jiaoyurong1990@163.com
About this study
Official title: Induction Chemotherapy Combined With Neoadjuvant Immunotherapy for MSS Colon Cancer: a Prospective Single-center Multi-arm Open-label Randomized Phase II Study
This study aims to elucidate the regression effects of neoadjuvant chemotherapy combined with immunotherapy and adjuvant therapy in locally advanced MSS colon cancer.
Read the detailed description
The standard treatment for locally advanced colon cancer is surgery followed by adjuvant chemotherapy containing oxaliplatin. The MOSAIC and 16968 studies have shown that approximately 30% of patients experience recurrence and metastasis within 6-7 years after surgery. Neoadjuvant chemotherapy may improve the prognosis of patients with malignant tumors. The significant tumor shrinkage after neoadjuvant therapy indicates a greater likelihood of long-term survival for patients. The OPTICAL and FoxTROT studies have shown that approximately 35% of patients are resistant to oxaliplatin-containing neoadjuvant chemotherapy, with a pCR rate of less than 10% and uncertain survival improvement. In addition, immunotherapy has poor efficacy for microsatellite stable (MSS) patients. Therefore, it is necessary to explore new and effective neoadjuvant treatment modalities for tumor regression.
The study will screen for individuals who are sensitive to oxaliplatin-containing regimens through induction chemotherapy. Immunogenic cell death will be enhanced by oxaliplatin-induced immunogenicity and combined with anti-programmed cell death ligand 1 (PD-L1) monoclonal antibodies for neoadjuvant therapy. In the context of cancer, the role of the intestinal microbiome in mediating immune activation induced by chemotherapy drugs has been demonstrated. Clostridium butyricum will be introduced as an adjuvant to explore the possibility of further increasing the significant response rate of neoadjuvant therapy.
The study will first conduct 2 cycles of Capox induction chemotherapy to screen for patients sensitive to chemotherapy. Patients will be randomized into three cohorts: one chemotherapy standard control cohort (continuing Capox chemotherapy for 2 cycles) and two enhancement design cohorts (Capox chemotherapy + Anti-PD-L1 monoclonal antibody for 2 cycles/Capox chemotherapy + Anti-PD-L1 monoclonal antibody + Clostridium butyricum for 2 cycles), followed by CME surgery. The study's primary endpoint is the proportion of Tumor regression grade(TRG)0/1 in the pathological specimens of surgically resected tumors.
- Conditions
- Colon Neoplasm
- Being tested
- Oxaliplatin, Capecitabine, Anti-PD-L1 Monoclonal Antibody, Clostridium butyricum, Colectomy
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxaliplatinDrug
Oxaliplatin 130mg/m2 for inducing chemotherapy on Day 1 every 3 weeks and repeat for 4 cycles. The dose reduction protocol for oxaliplatin-induced toxicity was implemented according to the report in BJC (2018) 118:1322-1328.
CapecitabineDrug
Oral Capecitabine 1000 mg/m2 twice daily combined with oxaliplatin chemotherapy from Day 1 to Day 14 every 3 weeks and repeat for 4 cycles. The dose reduction protocol for capecitabine-induced toxicity was implemented according to the report in BJC (2018) 118:1322-1328.
Anti-PD-L1 Monoclonal AntibodyDrug
Also called Envafolimab
The incidence of adverse events with Anti-PD-L1 Monoclonal Antibodies is relatively low. Based on phase I clinical trial data of Envafolimab, a dose reduction design was conducted to minimize the incidence of adverse events while ensuring therapeutic efficacy. In the two cohorts of the efficacy-enhancing design, a reduced dose of 100mg/0.5ml IH QW will be used for 6 weeks. The PD-L1 monoclonal antibody (Envafolimab) dose adjustment was implemented according to the prescribing information.
Clostridium butyricumDrug
Clostridium butyricum is treated with Miyarisan 588 powder, 160mg/day (4 packets/day) taken orally for a total of 6 weeks.There have been no reports of adverse reactions for Lactobacillus. There is no predetermined reduction plan.
ColectomyProcedure or surgery
The specific surgical approach, whether it be laparoscopic or open surgery, is determined by the surgeon. The tumor blood supply is ligated and cut at the root of the mesentery, and the margin of resection should be no less than 10cm. Complete resection of the mesocolon (CME) is performed in conjunction.
| Study group | Role | What they receive |
|---|---|---|
| Standard chemotherapy control cohort | Experimental | Patients with locally advanced colon cancer who met the inclusion criteria received two cycles of Capecitabine and Oxaliplatin （Capox） regimen chemotherapy and were evaluated by enhanced CT. Patients with more than 20% regression of maximum diameter of colon tumor in enhanced CT image will be randomly assigned to the Standard chemotherapy control cohort and continued with two more cycles of Capox chemotherapy. Then, these patients will receive curative surgery for colon cancer. Receives: Drug: Oxaliplatin; Drug: Capecitabine; Procedure: Colectomy |
| Enhancement regimen of combined Anti-PD-L1 monoclonal antibody | Experimental | Patients with locally advanced colon cancer who met the inclusion criteria received two cycles of Capecitabine and Oxaliplatin （Capox） regimen chemotherapy and were evaluated by enhanced CT. Patients with more than 20% regression of maximum diameter of colon tumor in enhanced CT image will be randomly assigned to the Enhancement regimen of combined Anti-PD-L1 monoclonal antibody and continued with two more cycles of Capox chemotherapy along with the reduced dosage of Anti-PD-L1 monoclonal antibody. Then, these patients will receive curative surgery for colon cancer. Receives: Drug: Oxaliplatin; Drug: Capecitabine; Drug: Anti-PD-L1 Monoclonal Antibody; Procedure: Colectomy |
| Enhancement regimen of combined lactobacillus and Anti-PD-L1 monoclonal antibody | Experimental | Patients with locally advanced colon cancer who met the inclusion criteria received two cycles of Capecitabine and Oxaliplatin （Capox） regimen chemotherapy and were evaluated by enhanced CT. Patients with more than 20% regression of maximum diameter of colon tumor in enhanced CT image will be randomly assigned to the Enhancement regimen of combined lactobacillus and Anti-PD-L1 monoclonal antibody and continued with two more cycles of Capox chemotherapy along with the reduced dosage of Anti-PD-L1 monoclonal antibody and Clostridium butyricum. Then, these patients will receive curative surgery for colon cancer. Receives: Drug: Oxaliplatin; Drug: Capecitabine; Drug: Anti-PD-L1 Monoclonal Antibody; Drug: Clostridium butyricum; Procedure: Colectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
TRG0/1
The sum of tumor regression grades TRG0(disappearance of tumor) and TRG1(scattered residual tumor)(AJCC standard).
Measured: 1 day of postoperative pathological examination.
Secondary outcomes (9)
AE
the rate of adverse event（AE).
Measured: Adverse events (NCI CTC AE 5.0) that occurred from the first day of induction chemotherapy to one day before the surgery date(up to half a year).
Surgical Complication
the rate of surgical complication during or after operation.
Measured: From the day of surgery to 30 days after the operation, including intraoperative and postoperative complications.
DFS
3-year Disease-free survival.
Measured: From date of the patient signs the informed consent form until the date of earliest occurrence of the patient's tumor recurrence or death，whichever came first, assessed up to 36 months.
OS
5-year Overall survival.
Measured: From the date of the patient signs the informed consent form until the date of the patient's death, assessed up to 60 months.
Concentration of FLT3L
Fms Related Receptor Tyrosine Kinase 3 Ligand is a marker of immunogenic cell death.
Measured: blood tests for FLT3LG at initial diagnosis, after induction chemotherapy, before and 3 months after surgery.
Concentration of cytokines
Blood density measurement of immunoreaction associated cytokines.
Measured: Blood tests of cytokines such as IFN-γ are conducted using techniques such as immunofluorescence and ELISA at initial diagnosis, after induction chemotherapy, before and 3 months after surgery.
T lymphocyte
Cells with cellular immune function.
Measured: The types and counts of T cells are analyzed using flow cytometry at initial diagnosis, after induction chemotherapy, before surgery, and 3 months after surgery.
Molecular pathological analysis of tumor tissue.
Whole exome sequencing and Nanostring to analyze changes in the tumor microenvironment immune status.
Measured: Nanostring and Whole exome gene sequencing is performed on tumor specimens to analyze the changes in immune cell types, counts, and other immune status-related factors in the tumor microenvironment before and after treatment (up to half a year).
Minimal Residual Disease (MRD)
Minimal Residual Disease which is a potential source of tumor recurrence and distant metastasis.
Measured: Collect plasma after surgery for MRD detection (up to half a year).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study startAug 2023 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon NeoplasmStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jun Li, MD, Study director, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05914389
- Sponsor's protocol ID
- 2023-0296
- Acronym
- ICONIC
- Status last verified
- Apr 2023
- First submitted
- 28 May 2023
- Last updated
- 8 Aug 2023
- Results posted
- 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 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induction Chemotherapy Combined With Neoadjuvant Immunotherapy for MSS Colon Cancer: a Prospective Single-center Multi-arm Open-label Randomized Phase II Study
- ClinicalTrials.gov ID
- NCT05914389
- Acronym / sponsor ID
- ICONIC / 2023-0296
- Conditions
- Colon Neoplasm
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- Aug 2023 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 22 Jun 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.
This study aims to elucidate the regression effects of neoadjuvant chemotherapy combined with immunotherapy and adjuvant therapy in locally advanced MSS colon cancer.
Detailed description
The standard treatment for locally advanced colon cancer is surgery followed by adjuvant chemotherapy containing oxaliplatin. The MOSAIC and 16968 studies have shown that approximately 30% of patients experience recurrence and metastasis within 6-7 years after surgery. Neoadjuvant chemotherapy may improve the prognosis of patients with malignant tumors. The significant tumor shrinkage after neoadjuvant therapy indicates a greater likelihood of long-term survival for patients. The OPTICAL and FoxTROT studies have shown that approximately 35% of patients are resistant to oxaliplatin-containing neoadjuvant chemotherapy, with a pCR rate of less than 10% and uncertain survival improvement. In addition, immunotherapy has poor efficacy for microsatellite stable (MSS) patients. Therefore, it is necessary to explore new and effective neoadjuvant treatment modalities for tumor regression.
The study will screen for individuals who are sensitive to oxaliplatin-containing regimens through induction chemotherapy. Immunogenic cell death will be enhanced by oxaliplatin-induced immunogenicity and combined with anti-programmed cell death ligand 1 (PD-L1) monoclonal antibodies for neoadjuvant therapy. In the context of cancer, the role of the intestinal microbiome in mediating immune activation induced by chemotherapy drugs has been demonstrated. Clostridium butyricum will be introduced as an adjuvant to explore the possibility of further increasing the significant response rate of neoadjuvant therapy.
The study will first conduct 2 cycles of Capox induction chemotherapy to screen for patients sensitive to chemotherapy. Patients will be randomized into three cohorts: one chemotherapy standard control cohort (continuing Capox chemotherapy for 2 cycles) and two enhancement design cohorts (Capox chemotherapy + Anti-PD-L1 monoclonal antibody for 2 cycles/Capox chemotherapy + Anti-PD-L1 monoclonal antibody + Clostridium butyricum for 2 cycles), followed by CME surgery. The study's primary endpoint is the proportion of Tumor regression grade(TRG)0/1 in the pathological specimens of surgically resected tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard chemotherapy control cohort | Experimental | Drug: Oxaliplatin, Drug: Capecitabine, Procedure: ColectomyPatients with locally advanced colon cancer who met the inclusion criteria received two cycles of Capecitabine and Oxaliplatin （Capox） regimen chemotherapy and were evaluated by enhanced CT. Patients with more than 20% regression of maximum diameter of colon tumor in enhanced CT image will be randomly assigned to the Standard chemotherapy control cohort and continued with two more cycles of Capox chemotherapy. Then, these patients will receive curative surgery for colon cancer. |
| Enhancement regimen of combined Anti-PD-L1 monoclonal antibody | Experimental | Drug: Oxaliplatin, Drug: Capecitabine, Drug: Anti-PD-L1 Monoclonal Antibody, Procedure: ColectomyPatients with locally advanced colon cancer who met the inclusion criteria received two cycles of Capecitabine and Oxaliplatin （Capox） regimen chemotherapy and were evaluated by enhanced CT. Patients with more than 20% regression of maximum diameter of colon tumor in enhanced CT image will be randomly assigned to the Enhancement regimen of combined Anti-PD-L1 monoclonal antibody and continued with two more cycles of Capox chemotherapy along with the reduced dosage of Anti-PD-L1 monoclonal antibody. Then, these patients will receive curative surgery for colon cancer. |
| Enhancement regimen of combined lactobacillus and Anti-PD-L1 monoclonal antibody | Experimental | Drug: Oxaliplatin, Drug: Capecitabine, Drug: Anti-PD-L1 Monoclonal Antibody, Drug: Clostridium butyricum, Procedure: ColectomyPatients with locally advanced colon cancer who met the inclusion criteria received two cycles of Capecitabine and Oxaliplatin （Capox） regimen chemotherapy and were evaluated by enhanced CT. Patients with more than 20% regression of maximum diameter of colon tumor in enhanced CT image will be randomly assigned to the Enhancement regimen of combined lactobacillus and Anti-PD-L1 monoclonal antibody and continued with two more cycles of Capox chemotherapy along with the reduced dosage of Anti-PD-L1 monoclonal antibody and Clostridium butyricum. Then, these patients will receive curative surgery for colon cancer. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 years old and ≤75 years old.
- Pathologically diagnosed MSS or pMMR-type colon adenocarcinoma.
- The lower edge of the tumor is more than 12cm from the anus as measured by colonoscopy and the lower edge of the tumor cannot be directly palpated during rectal examination.
- Enhanced CT stage T3/4 or T1-4N+ without multiple primary tumors or distant metastasis.
- Life expectancy is expected to be more than 1 year.
Key exclusion criteria (13 listed)
- Refused to participate in this study.
- Multifocal colorectal cancer.
- History of malignant tumors, except for basal cell carcinoma, papillary thyroid carcinoma, and various in situ cancers.
- Cannot tolerate chemotherapy, such as but not limited to bone marrow suppression.
- Acute exacerbation of important organ diseases (such as but not limited to COPD, coronary heart disease, and renal insufficiency) and/or severe acute infectious diseases (such as but not limited to hepatitis, pneumonia, and myocarditis), ASA score > 3 points.
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 |
|---|---|---|
| OxaliplatinOxaliplatin 130mg/m2 for inducing chemotherapy on Day 1 every 3 weeks and repeat for 4 cycles. The dose reduction protocol for oxaliplatin-induced toxicity was implemented according to the report in BJC (2018) 118:1322-1328. | Drug | Enhancement regimen of combined Anti-PD-L1 monoclonal antibody, Enhancement regimen of combined lactobacillus and Anti-PD-L1 monoclonal antibody, Standard chemotherapy control cohort |
| CapecitabineOral Capecitabine 1000 mg/m2 twice daily combined with oxaliplatin chemotherapy from Day 1 to Day 14 every 3 weeks and repeat for 4 cycles. The dose reduction protocol for capecitabine-induced toxicity was implemented according to the report in BJC (2018) 118:1322-1328. | Drug | Enhancement regimen of combined Anti-PD-L1 monoclonal antibody, Enhancement regimen of combined lactobacillus and Anti-PD-L1 monoclonal antibody, Standard chemotherapy control cohort |
| Anti-PD-L1 Monoclonal AntibodyAlso: EnvafolimabThe incidence of adverse events with Anti-PD-L1 Monoclonal Antibodies is relatively low. Based on phase I clinical trial data of Envafolimab, a dose reduction design was conducted to minimize the incidence of adverse events while ensuring therapeutic efficacy. In the two cohorts of the efficacy-enhancing design, a reduced dose of 100mg/0.5ml IH QW will be used for 6 weeks. The PD-L1 monoclonal antibody (Envafolimab) dose adjustment was implemented according to the prescribing information. | Drug | Enhancement regimen of combined Anti-PD-L1 monoclonal antibody, Enhancement regimen of combined lactobacillus and Anti-PD-L1 monoclonal antibody |
| Clostridium butyricumClostridium butyricum is treated with Miyarisan 588 powder, 160mg/day (4 packets/day) taken orally for a total of 6 weeks.There have been no reports of adverse reactions for Lactobacillus. There is no predetermined reduction plan. | Drug | Enhancement regimen of combined lactobacillus and Anti-PD-L1 monoclonal antibody |
| ColectomyThe specific surgical approach, whether it be laparoscopic or open surgery, is determined by the surgeon. The tumor blood supply is ligated and cut at the root of the mesentery, and the margin of resection should be no less than 10cm. Complete resection of the mesocolon (CME) is performed in conjunction. | Procedure or surgery | Enhancement regimen of combined Anti-PD-L1 monoclonal antibody, Enhancement regimen of combined lactobacillus and Anti-PD-L1 monoclonal antibody, Standard chemotherapy control cohort |
Primary outcome
TRG0/1
Time frame: 1 day of postoperative pathological examination.
The sum of tumor regression grades TRG0(disappearance of tumor) and TRG1(scattered residual tumor)(AJCC standard).
9 secondary outcomes
AE
Time frame: Adverse events (NCI CTC AE 5.0) that occurred from the first day of induction chemotherapy to one day before the surgery date(up to half a year).
Surgical Complication
Time frame: From the day of surgery to 30 days after the operation, including intraoperative and postoperative complications.
DFS
Time frame: From date of the patient signs the informed consent form until the date of earliest occurrence of the patient's tumor recurrence or death，whichever came first, assessed up to 36 months.
OS
Time frame: From the date of the patient signs the informed consent form until the date of the patient's death, assessed up to 60 months.
Concentration of FLT3L
Time frame: blood tests for FLT3LG at initial diagnosis, after induction chemotherapy, before and 3 months after surgery.
Concentration of cytokines
Time frame: Blood tests of cytokines such as IFN-γ are conducted using techniques such as immunofluorescence and ELISA at initial diagnosis, after induction chemotherapy, before and 3 months after surgery.
T lymphocyte
Time frame: The types and counts of T cells are analyzed using flow cytometry at initial diagnosis, after induction chemotherapy, before surgery, and 3 months after surgery.
Molecular pathological analysis of tumor tissue.
Time frame: Nanostring and Whole exome gene sequencing is performed on tumor specimens to analyze the changes in immune cell types, counts, and other immune status-related factors in the tumor microenvironment before and after treatment (up to half a year).
Minimal Residual Disease (MRD)
Time frame: Collect plasma after surgery for MRD detection (up to half a 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 8 Aug 2023.
- 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.
Jun Li, MD study director
Second Affiliated Hospital, Zhejiang University, School of Medicine
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 Oxaliplatin, Capecitabine and Anti-PD-L1 Monoclonal Antibody in people with Colon Neoplasm, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 13 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 8 Aug 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?
Contact Li Jun, MD (+86 13777878061, 2307016@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TRG0/1 (time frame: 1 day of postoperative pathological examination.). 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 8 Aug 2023.