Colorectal CancerNACSOC-02NCT05202314
Camrelizumab Combined With Neoadjuvant Chemotherapy After Stent Placement for Left-Sided Obstructive Colonic Cancer
A study testing Immunotherapy (Camrelizumab) in people with Colorectal Cancer and Neoadjuvant Chemotherapy, run by Beijing Chao Yang Hospital at 1 site in China.
Trial summary
Patients with obstruction are associated with worse oncologic outcomes compared with those having nonobstructive tumors. Conventionally, patients with malignant large bowel obstruction receive emergency surgery, with morbidity rates of 30%-60% and mortality rates of 7-22%, and about two-thirds of such patients end up… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Cancer, Neoadjuvant Chemotherapy, Stent
- What is being tested?
- Immunotherapy (Camrelizumab)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 12 Dec 2021to 30 Dec 2026
- Phase
- Interventional
- 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
- Radiologically proven colonic obstruction of the left colon/upper rectum presumed secondary to a carcinoma
- Able to give written, informed consent
- Primary tumor was resectable
- ECOG score 0 or 1
- Haemoglobin greater than 100 g/L after transfusion before chemotherapy,
- White blood cells greater than 3.0×10# /L
Show all 10Show fewer
- Platelets greater than 100×10# / L;
- Glomerular filtration rate greater than 50 mL per minute as calculated by the Wright or Cockroft formula
- Bilirubin less than 1.5×Upper Limit of Normal(ULN)
- ALT and AST less than 2.5×ULN
Who cannot join
- Distal rectal cancers(equal or less than 10cm from the anal verge)
- Patients with signs of peritonitis and/or bowel perforation
- Patients who did not give informed consent
- Patients who were considered unfit for operative treatment or refuse surgery.
- Patients with suspected or proven metastatic adenocarcinoma;
- Patients with unresectable colorectal cancer, or planning for palliative treatment.
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
Beijing Chaoyang Hospital, Capital Medical University
Beijing, Beijing Municipality, 100020
Zhen Jun Wang, M.D., 86-013601393711, drzhenjun@163.com
Zhen Jun Wang
About this study
Official title: Camrelizumab Combined With Neoadjuvant Chemotherapy After Stent Placement Versus Surgery Alone for Left-Sided Obstructive Colonic Cancer
Patients with obstruction are associated with worse oncologic outcomes compared with those having nonobstructive tumors. Conventionally, patients with malignant large bowel obstruction receive emergency surgery, with morbidity rates of 30%-60% and mortality rates of 7-22%, and about two-thirds of such patients end up with a permanent stoma. Self-expanding metallic stents (SEMS) haven been used as a bridge to surgery (to relieve obstruction prior to elective surgery) in patients with potentially resectable colorectal cancer. Several clinical trials demonstrate that SEMS as a bridge to surgery may be superior to emergency surgery considering the short-term outcomes. SEMS is associated with lower morbidity and mortality rate, increased primary anastomosis rate, and decreased stoma creation rate. Although about half of patients can achieve primary anastomosis after stent placement, the primary anastomosis rate is still significantly lower compared with nonobstructing elective surgery. The interval between stent placement and surgery may be not long enough that bowel decompression is insufficient at the time of operation. Furthermore#the long-term oncologic results regarding SEMS as a bridge to surgery are still limited and contradictory. Sabbagh et al. suggest worse overall survival of patients with SEMS insertion compared with emergency surgery, the 5-year cancer-specific mortality was significantly higher in the SEMS group (48% vs 21%, respectively, P=0.02). One interpretation is that tumor cells may disseminate during the procedure of colonic stenting placement. Immunotherapy has proven to be highly effective as first-line treatment of metastatic colorectal cancer (CRC). And immunotherapy also has emerged as a neoadjuvant approach, possibly changing treatment strategy for both primary resectable and metastatic CRC. We hypothesis that, regardless of the MSI state, immunotherapy (Camrelizumab, an anti-PD-1 antibody) combined with chemotherapy after stenting may improve overall survival by eradicating micrometastasis. Moreover, immunotherapy (Camrelizumab, an anti-PD-1 antibody) combined with neoadjuvant chemotherapy prolongs the interval between stent placement and surgery, and the time for bowel decompression is more sufficient, which may increase the success rate of primary anastomosis and decrease risk of stoma formation, and furthermore, improve OS and PFS.
Read the detailed description
We hypothesis that, regardless of the MSI state, immunotherapy combined with immediate chemotherapy after stenting may improve overall survival by eradicating micrometastasis. Moreover, immunotherapy (Camrelizumab, an anti-PD-1 antibody) combined with neoadjuvant chemotherapy prolongs the interval between stent placement and surgery, and the time for bowel decompression is more sufficient, which may increase the success rate of primary anastomosis and decrease risk of stoma formation, and furthermore, improve OS and PFS.
- Conditions
- Colorectal Cancer, Neoadjuvant Chemotherapy, Stent, Obstruction, Immunotherapy
- Being tested
- Immunotherapy (Camrelizumab)
- Medical subject headings
- Colorectal Neoplasms, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunotherapy (Camrelizumab)Drug
Also called Chemotheray (CAPOX or mFOLFOX6)
After clinical success of colonic stenting, regardless of the MSI state, patients will receive Immunotherapy (Camrelizumab 200mg) for 2 cycles compined with neoadjuvant chemotherapy with mFOLFOX6 regimen for 3 cycles or CapeOx regimen for 2 cycles. Patients will undergo surgery 2-3 weeks after the last cycle chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Immunotherapy group | Experimental | After clinical success of colonic stenting, regardless of the MSI state all patients will receive Immunotherapy (Camrelizumab 200mg) for 2 cycles compined with neoadjuvant chemotherapy with mFOLFOX6 regimen for 3 cycles or CapeOx regimen for 2 cycles. Patients will undergo surgery 2-3 weeks after the last cycle of chemotherapy, type and extent of the surgery will be selected by the surgeon. Receives: Drug: Immunotherapy (Camrelizumab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete remission
No tumor cell found in surgical specimens
Measured: 2 weeks after patients received radical operation
Secondary outcomes (2)
Disease Free Survival
No tumor regrowth or recurrence or metastasis found
Measured: 3 years after operation
Overall Survival
Survive during following
Measured: 3 years after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start12 Dec 2021
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Beijing Chao Yang 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhen Jun Wang, Beijing Chao Yang Hospital
- Investigators
- Zhen Jun Wang, MD, Principal investigator, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05202314
- Sponsor's protocol ID
- 2021-12-24
- Acronym
- NACSOC-02
- Status last verified
- Feb 2023
- First submitted
- 10 Jan 2022
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Camrelizumab Combined With Neoadjuvant Chemotherapy After Stent Placement Versus Surgery Alone for Left-Sided Obstructive Colonic Cancer
- ClinicalTrials.gov ID
- NCT05202314
- Acronym / sponsor ID
- NACSOC-02 / 2021-12-24
- Conditions
- Colorectal Cancer, Neoadjuvant Chemotherapy, Stent, Obstruction, Immunotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Study start
- 12 Dec 2021 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 21 Jan 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.
Patients with obstruction are associated with worse oncologic outcomes compared with those having nonobstructive tumors. Conventionally, patients with malignant large bowel obstruction receive emergency surgery, with morbidity rates of 30%-60% and mortality rates of 7-22%, and about two-thirds of such patients end up with a permanent stoma. Self-expanding metallic stents (SEMS) haven been used as a bridge to surgery (to relieve obstruction prior to elective surgery) in patients with potentially resectable colorectal cancer. Several clinical trials demonstrate that SEMS as a bridge to surgery may be superior to emergency surgery considering the short-term outcomes. SEMS is associated with lower morbidity and mortality rate, increased primary anastomosis rate, and decreased stoma creation rate. Although about half of patients can achieve primary anastomosis after stent placement, the primary anastomosis rate is still significantly lower compared with nonobstructing elective surgery. The interval between stent placement and surgery may be not long enough that bowel decompression is insufficient at the time of operation. Furthermore#the long-term oncologic results regarding SEMS as a bridge to surgery are still limited and contradictory. Sabbagh et al. suggest worse overall survival of patients with SEMS insertion compared with emergency surgery, the 5-year cancer-specific mortality was significantly higher in the SEMS group (48% vs 21%, respectively, P=0.02). One interpretation is that tumor cells may disseminate during the procedure of colonic stenting placement. Immunotherapy has proven to be highly effective as first-line treatment of metastatic colorectal cancer (CRC). And immunotherapy also has emerged as a neoadjuvant approach, possibly changing treatment strategy for both primary resectable and metastatic CRC. We hypothesis that, regardless of the MSI state, immunotherapy (Camrelizumab, an anti-PD-1 antibody) combined with chemotherapy after stenting may improve overall survival by eradicating micrometastasis. Moreover, immunotherapy (Camrelizumab, an anti-PD-1 antibody) combined with neoadjuvant chemotherapy prolongs the interval between stent placement and surgery, and the time for bowel decompression is more sufficient, which may increase the success rate of primary anastomosis and decrease risk of stoma formation, and furthermore, improve OS and PFS.
Detailed description
We hypothesis that, regardless of the MSI state, immunotherapy combined with immediate chemotherapy after stenting may improve overall survival by eradicating micrometastasis. Moreover, immunotherapy (Camrelizumab, an anti-PD-1 antibody) combined with neoadjuvant chemotherapy prolongs the interval between stent placement and surgery, and the time for bowel decompression is more sufficient, which may increase the success rate of primary anastomosis and decrease risk of stoma formation, and furthermore, improve OS and PFS.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Immunotherapy group | Experimental | Drug: Immunotherapy (Camrelizumab)After clinical success of colonic stenting, regardless of the MSI state all patients will receive Immunotherapy (Camrelizumab 200mg) for 2 cycles compined with neoadjuvant chemotherapy with mFOLFOX6 regimen for 3 cycles or CapeOx regimen for 2 cycles. Patients will undergo surgery 2-3 weeks after the last cycle of chemotherapy, type and extent of the surgery will be selected by the surgeon. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Radiologically proven colonic obstruction of the left colon/upper rectum presumed secondary to a carcinoma
- Able to give written, informed consent
- Primary tumor was resectable
- ECOG score 0 or 1
- Haemoglobin greater than 100 g/L after transfusion before chemotherapy,
Key exclusion criteria (6 listed)
- Distal rectal cancers(equal or less than 10cm from the anal verge)
- Patients with signs of peritonitis and/or bowel perforation
- Patients who did not give informed consent
- Patients who were considered unfit for operative treatment or refuse surgery.
- Patients with suspected or proven metastatic adenocarcinoma;
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 |
|---|---|---|
| Immunotherapy (Camrelizumab)Also: Chemotheray (CAPOX or mFOLFOX6)After clinical success of colonic stenting, regardless of the MSI state, patients will receive Immunotherapy (Camrelizumab 200mg) for 2 cycles compined with neoadjuvant chemotherapy with mFOLFOX6 regimen for 3 cycles or CapeOx regimen for 2 cycles. Patients will undergo surgery 2-3 weeks after the last cycle chemotherapy | Drug | Immunotherapy group |
Primary outcome
Pathological complete remission
Time frame: 2 weeks after patients received radical operation
No tumor cell found in surgical specimens
2 secondary outcomes
Disease Free Survival
Time frame: 3 years after operation
Overall Survival
Time frame: 3 years after operation
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 Feb 2023.
- Individual participant dataSharing planned: No
Related trials for Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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.
Zhen Jun Wang, MD principal investigator
Beijing Chao Yang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immunotherapy (Camrelizumab) in people with Colorectal Cancer and Neoadjuvant Chemotherapy, run by Beijing Chao Yang 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 10 inclusion and 6 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 21 Feb 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.
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 Jia Gang Han, MD (+861085231604, hjg211@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete remission (time frame: 2 weeks after patients received radical operation). 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 Feb 2023.