Rectal AdenocarcinomaPhase 2NCT06266832
The Efficacy and Safety of Short-course Radiation Combined With Adebrelimab and CAPEOX Neo-adjuvant Therapy for Organ-retention in Patients With MSS/pMMR Ultra Low Rectal Adenocarcinoma
A Phase 2 study testing Adebrelimab, Oxaliplatin and Capecitabine in people with Rectal Adenocarcinoma, run by Sir Run Run Shaw Hospital at 1 site in China.
Trial summary
To evaluate the efficacy, safety and organ retention rate of short-course radiation combined with Adebrelimab and CAPEOX neoadjuvant therapy in patients with MSS/pMMR ultra low rectal adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Adenocarcinoma
- What is being tested?
- Adebrelimab, Oxaliplatin and Capecitabine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 31 Dec 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are willing to receive neoadjuvant therapy.
- ≧18 years old.
- Diagnosed by digital rectal examination, colonoscopy, and high-resolution MRI of the pelvis, the tumor is less than or equal to 5 cm from the anus.
- Histologically diagnosed as rectal adenocarcinoma.
- MMR protein detection or MSI gene detection of rectal cancer specimens confirmed pMMR or MSS before treatment .
- The clinical staging by pelvic contrast-enhanced CT and pelvic high-resolution MRI were stage I, II and III.
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- The patient has good compliance and can come to the hospital for re-examination as required.
- ECOG Scale of Performance Status score 0-1 point.
- Have not received anti-tumor and immunotherapy before enrollment.
- Laboratory inspections must meet the following standards:
- White blood cell count>3.5×109/L, absolute value of neutrophils>1.8×109/L, platelet count ≥75×109/L, hemoglobin ≥100g/L;
- INR≤1.5, and APTT≤1.5 times the upper limit of normal or partial prothrombin time (PT) ≤1.5 times the upper limit of normal;
- Total bilirubin ≤ 1.25 times the upper limit of normal; ALT and AST < 5 times the upper limit of normal;
- 24h creatinine clearance >50mL/min or serum creatinine <1.5 times the upper limit of normal.
- Voluntarily participate in this study and sign the informed consent.
Who cannot join
- History of other malignant diseases other than rectal cancer in the past 5 years.
- Patients with metastases from other sites (stage IV patients).
- Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc. requiring emergency surgery.
- Known allergic to oxaliplatin, capecitabine, Adebrelimab and other drugs.
- Pathologically suggested signet ring cell carcinoma and mucinous adenocarcinoma.
- dMMR or MSI-H patients.
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- The patient is accompanied by any unstable systemic disease, including but not limited to: severe infection, uncontrolled diabetes, hypertension uncontrolled by medication, unstable angina, cerebrovascular accident or transient cerebral ischemia, myocardial Infarction, congestive heart failure, severe cardiac arrhythmia requiring medication, hepatic, renal or metabolic disease; disease affecting the patient's life.
- The disease (such as mental illness, etc.) or condition (such as alcoholism or drug abuse, etc.) associated with the patient will increase the risk of the patient receiving the trial drug treatment or affect the patient's compliance with the trial requirements, or may confuse the research results.
- Active autoimmune disease that may worsen while receiving immunostimulants.
- Known history of positive HIV test or known acquired immunodeficiency syndrome.
- Patients who are using immunosuppressive agents, except for the following conditions:
- Intranasal, inhaled, topical steroids, or topical steroid injections (eg, intra-articular injections);
- Physiological doses of systemic corticosteroids ≤10 mg/day prednisone or equivalent; 3) Steroids used to prevent allergic reactions (eg, before CT scan).
- Received any other experimental drug treatment or participated in another interventional clinical trial within 30 days before screening.
- Women who are pregnant or breastfeeding or who plan to become pregnant or breastfeeding during the study period; men or women who are unwilling to take effective contraceptive measures.
- Vulnerable groups, including mentally ill, cognitively impaired, critically ill patients, minors, etc.
- Other conditions that the investigator judges that the patient is not suitable to participate in the clinical study, etc.
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
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310016
Xiujun Cai
About this study
Official title: The Efficacy and Safety of Short-course Radiation Combined With Adebrelimab and CAPEOX Neo-adjuvant Therapy for Organ-retention in Patients With MSS/pMMR Ultra Low Rectal Adenocarcinoma: A Prospective, Single-arm Study
To evaluate the efficacy, safety and organ retention rate of short-course radiation combined with Adebrelimab and CAPEOX neoadjuvant therapy in patients with MSS/pMMR ultra low rectal adenocarcinoma.
Read the detailed description
At present, neoadjuvant chemoradiotherapy (nCRT) combined with total mesorectal excision (TME) is the main standard treatment, and the choice of treatment modalities is limited. The emergence of immunotherapy has provided a new direction for the exploration of neoadjuvant therapy for rectal adenocarcinoma. At the same time, a number of studies have also shown that appropriate radiotherapy intensity can promote immune response. Therefore, the investigators intend to conduct the clinical trail to explore the effect of short-course radiotherapy combined with PD-L1 combined and chemotherapy as TNT (total neoadjuvant therapy) on organ retention rate in patients with With MSS/pMMR Ultra Low Rectal Adenocarcinoma.
- Conditions
- Rectal Adenocarcinoma
- Being tested
- Adebrelimab, Oxaliplatin, Capecitabine, Short-course Radiation, Biopsy
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdebrelimabDrug
Also called SHR-1316
This product is administered by intravenously guttae. The recommended dose of subcutaneous injection is 20mg/kg, administered every 3 Weeks (Q3W).
OxaliplatinDrug
130mg/m2, ivgtt, d1, Q3W
CapecitabineDrug
1000mg/m2, po, bid, d1-14, Q3W
Short-course RadiationRadiation
Short-course radiotherapy, using three-dimensional conformal or intensity-modulated radiotherapy, the dose is divided into 5Gy/f, the total dose is 25Gy/5f, 1f/d, and the irradiation is completed within 7 days.
BiopsyProcedure or surgery
local excision or TME surgery (total mesorectal excision) Biopsy can choose endoscopic or needle biopsy, colcal excision refers to excison of the local lession after total neoadjuvant therapy. The total mesorectal excision can choose open, laparoscopic or robotic according to the specific condition of the patient.
| Study group | Role | What they receive |
|---|---|---|
| Total Neoadjuvant Therapy with Short-course Radiation followed by Adebrelimab plus CAPEOX | Experimental | The enrolled patients with MSS-type advanced ultra low rectal adenocarcinoma will receive a combined regimen of neoadjuvant chemoradiotherapy combined with immunotherapy and biopsy or local excision.
Radiotherapy uses a short-range mode, irradiating the primary tumor and high-risk areas with dose of 25 Gy.
After radiotherapy, PD-L1 antibody (20mg/kg, intravenously guttae, 2courses) immunotherapy combined with 2 courses of CAPEOX chemotherapy was performed.
1-4 weeks after the end of the combined treatment plan in step 2), biopsy or local excision of the lesion is performed. Receives: Drug: Adebrelimab; Drug: Oxaliplatin; Drug: Capecitabine; Radiation: Short-course Radiation; Procedure: Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Organ retention rate
population who achieve complete clinical response after total neoadjuvant therapy
Measured: After 2 weeks (once biopsy or local excision is done)
Secondary outcomes (7)
Total mesorectal excision rate
population who not achieve complete clinical response after total neoadjuvant therapy
Measured: After 2 weeks (once biopsy or local excision is done)
Total mesorectal excision rate after recurrence
population who recurrent and have Salvage total mesorectal excision after achieving complete clinical response after total neoadjuvant therapy
Measured: from primary evaluation at 2 weeks after total neoadjuvant therapy finished
Tumor regression grade
Tumor regression grade following short-course radiation then Envafolimab Plus CAPEOX as assessed by AJCC/CAP TRG system
Measured: After 2 weeks (once biopsy or local excision is done)
Overall survival
The proportion of participants who remain survival at 3 years
Measured: Up to 3 years
Disease free survival
The time from randomization to the first event of either recurrent disease or death
Measured: Up to 3 years
TRAEs
Number of participants with treatment-related adverse events as assessed by NCI-CTCAE v5.0
Measured: Up to 3 years
QoL
Quality of life of the patients in total neoadjuvant settings of short-course radiation followed with Adebrelimab Plus CAPEOX as assessed by Functional Assessment of Cancer Therapy - Colorectal (FACT-C) questionnaire liscenced from The Functional Assessment of Chronic Illness Therapy System ("FACIT System"). By using the Manual scoring template, some items are reverse scored. Subscale scores, total scores and TOI scores. The higher the score, the better the QOL.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start1 Jan 2024
- Primary completion1 Jan 2025 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal AdenocarcinomaStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sir Run Run Shaw Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- sheng dai, MD&PhD, Principal investigator, China, Zhejiang Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06266832
- Sponsor's protocol ID
- 20230727
- Status last verified
- Feb 2024
- First submitted
- 28 Jan 2024
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- 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 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Short-course Radiation Combined With Adebrelimab and CAPEOX Neo-adjuvant Therapy for Organ-retention in Patients With MSS/pMMR Ultra Low Rectal Adenocarcinoma: A Prospective, Single-arm Study
- ClinicalTrials.gov ID
- NCT06266832
- Acronym / sponsor ID
- 20230727
- Conditions
- Rectal Adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sir Run Run Shaw HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 Feb 2024 (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.
To evaluate the efficacy, safety and organ retention rate of short-course radiation combined with Adebrelimab and CAPEOX neoadjuvant therapy in patients with MSS/pMMR ultra low rectal adenocarcinoma.
Detailed description
At present, neoadjuvant chemoradiotherapy (nCRT) combined with total mesorectal excision (TME) is the main standard treatment, and the choice of treatment modalities is limited. The emergence of immunotherapy has provided a new direction for the exploration of neoadjuvant therapy for rectal adenocarcinoma. At the same time, a number of studies have also shown that appropriate radiotherapy intensity can promote immune response. Therefore, the investigators intend to conduct the clinical trail to explore the effect of short-course radiotherapy combined with PD-L1 combined and chemotherapy as TNT (total neoadjuvant therapy) on organ retention rate in patients with With MSS/pMMR Ultra Low Rectal Adenocarcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Total Neoadjuvant Therapy with Short-course Radiation followed by Adebrelimab plus CAPEOX | Experimental | Drug: Adebrelimab, Drug: Oxaliplatin, Drug: Capecitabine, Radiation: Short-course Radiation, Procedure: BiopsyThe enrolled patients with MSS-type advanced ultra low rectal adenocarcinoma will receive a combined regimen of neoadjuvant chemoradiotherapy combined with immunotherapy and biopsy or local excision. Radiotherapy uses a short-range mode, irradiating the primary tumor and high-risk areas with dose of 25 Gy. After radiotherapy, PD-L1 antibody (20mg/kg, intravenously guttae, 2courses) immunotherapy combined with 2 courses of CAPEOX chemotherapy was performed. 1-4 weeks after the end of the combined treatment plan in step 2), biopsy or local excision of the lesion is performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients who are willing to receive neoadjuvant therapy.
- ≧18 years old.
- Diagnosed by digital rectal examination, colonoscopy, and high-resolution MRI of the pelvis, the tumor is less than or equal to 5 cm from the anus.
- Histologically diagnosed as rectal adenocarcinoma.
- MMR protein detection or MSI gene detection of rectal cancer specimens confirmed pMMR or MSS before treatment .
Key exclusion criteria (17 listed)
- History of other malignant diseases other than rectal cancer in the past 5 years.
- Patients with metastases from other sites (stage IV patients).
- Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc. requiring emergency surgery.
- Known allergic to oxaliplatin, capecitabine, Adebrelimab and other drugs.
- Pathologically suggested signet ring cell carcinoma and mucinous 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 |
|---|---|---|
| AdebrelimabAlso: SHR-1316This product is administered by intravenously guttae. The recommended dose of subcutaneous injection is 20mg/kg, administered every 3 Weeks (Q3W). | Drug | Total Neoadjuvant Therapy with Short-course Radiation followed by Adebrelimab plus CAPEOX |
| Oxaliplatin130mg/m2, ivgtt, d1, Q3W | Drug | Total Neoadjuvant Therapy with Short-course Radiation followed by Adebrelimab plus CAPEOX |
| Capecitabine1000mg/m2, po, bid, d1-14, Q3W | Drug | Total Neoadjuvant Therapy with Short-course Radiation followed by Adebrelimab plus CAPEOX |
| Short-course RadiationShort-course radiotherapy, using three-dimensional conformal or intensity-modulated radiotherapy, the dose is divided into 5Gy/f, the total dose is 25Gy/5f, 1f/d, and the irradiation is completed within 7 days. | Radiation | Total Neoadjuvant Therapy with Short-course Radiation followed by Adebrelimab plus CAPEOX |
| Biopsylocal excision or TME surgery (total mesorectal excision) Biopsy can choose endoscopic or needle biopsy, colcal excision refers to excison of the local lession after total neoadjuvant therapy. The total mesorectal excision can choose open, laparoscopic or robotic according to the specific condition of the patient. | Procedure or surgery | Total Neoadjuvant Therapy with Short-course Radiation followed by Adebrelimab plus CAPEOX |
Primary outcome
Organ retention rate
Time frame: After 2 weeks (once biopsy or local excision is done)
population who achieve complete clinical response after total neoadjuvant therapy
7 secondary outcomes
Total mesorectal excision rate
Time frame: After 2 weeks (once biopsy or local excision is done)
Total mesorectal excision rate after recurrence
Time frame: from primary evaluation at 2 weeks after total neoadjuvant therapy finished
Tumor regression grade
Time frame: After 2 weeks (once biopsy or local excision is done)
Overall survival
Time frame: Up to 3 years
Disease free survival
Time frame: Up to 3 years
TRAEs
Time frame: Up to 3 years
QoL
Time frame: Up to 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 20 Feb 2024.
- 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.
sheng dai, MD&PhD principal investigator
China, Zhejiang Sir Run Run Shaw 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 Adebrelimab, Oxaliplatin and Capecitabine in people with Rectal Adenocarcinoma, run by Sir Run Run Shaw 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 15 inclusion and 17 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 20 Feb 2024. 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 sheng dai, MD&PhD (13575472669, daimd@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Organ retention rate (time frame: After 2 weeks (once biopsy or local excision is done)). 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 20 Feb 2024.