Rectal AdenocarcinomaPhase 2SCRIPBOTNCT06872606
Short-Course Radiotherapy Combined with Intracavitary Brachytherapy Followed by Pucotenlimab, Bevacizumab, Oxaliplatin, and Trifluridine/Tipiracil (TAS-102) for Total Neoadjuvant Therapy of Microsatellite Stable (MSS) Locally Advanced Low Rectal Cancer
A Phase 2 study testing Pucotenlimab, Bevacizumab and Oxaliplatin in people with Rectal Adenocarcinoma, run by Sir Run Run Shaw Hospital at 1 site in China.
Trial summary
A Prospective Single-Arm Study of Short-Course Radiotherapy Followed by PD-1 Monoclonal Antibody, Bevacizumab, Oxaliplatin, and Trifluridine/Tipiracil for Total Neoadjuvant Therapy in MSS Locally Advanced Low Rectal Cancer. This is a Non-Randomized, Single Group Assignment, Open Label, Phase: Phase II study. 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?
- Pucotenlimab, Bevacizumab and Oxaliplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2025to 1 Apr 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 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.
- Clinical stage: cT2-4a N+ or cT3/T4a N0 (MRI/CT-confirmed).
- MSS/pMMR status confirmed by immunohistochemistry or PCR before treatment .
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- ECOG Scale of Performance Status score 0-1 point.
- Adequate organ function (hematologic, hepatic, renal).
- Have not received anti-tumor and immunotherapy before enrollment.
- Laboratory inspections must meet the following standards:
- 1) White blood cell count>3.5×109/L, absolute value of neutrophils>1.8×109/L, platelet count ≥75×109/L, hemoglobin ≥100g/L; 2) 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; 3) Total bilirubin ≤ 1.25 times the upper limit of normal; ALT and AST < 5 times the upper limit of normal; 4) 24h creatinine clearance >50mL/min or serum creatinine <1.5 times the upper limit of normal.
- 11. Voluntarily participate in this study and sign the informed consent.
Who cannot join
- History of other malignant diseases in the past 5 years.
- Patients with metastases from other sites (stage IV patients).
- Patients withT4b or positive lateral lymph nodes by pelvic contrast-enhanced CT and pelvic high-resolution MRI.
- Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc. requiring emergency surgery.
- Known allergic to oxaliplatin, PD-1 monoclonal antibody and other intervention drugs.
- Pathologically suggested signet ring cell carcinoma and mucinous adenocarcinoma.
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- dMMR or MSI-H patients.
- 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:
- 1) Intranasal, inhaled, topical steroids, or topical steroid injections (eg, intra-articular injections); 2) Physiological doses of systemic corticosteroids ≤10 mg/day prednisone or equivalent; 3) Steroids used to prevent allergic reactions (eg, before CT scan). 13. Received any other experimental drug treatment or participated in another interventional clinical trial within 30 days before screening 14. 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.
- 15. Vulnerable groups, including mentally ill, cognitively impaired, critically ill patients, minors, etc.
- 16. 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
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310016
Xiujun Cai, +86-057186090073, cxjzu@hotmail.com
About this study
Official title: The Efficacy and Safety of Short-Course Radiotherapy Combined with Intracavitary Brachytherapy Followed by Pucotenlimab, Bevacizumab, Oxaliplatin, and Trifluridine/Tipiracil (TAS-102) for Total Neoadjuvant Therapy of Microsatellite Stable (MSS) Locally Advanced Low Rectal Adenocarcinoma: an Prospective, Single Arm Clinical Trial （SCRIPBOT Trial）
A Prospective Single-Arm Study of Short-Course Radiotherapy Followed by PD-1 Monoclonal Antibody, Bevacizumab, Oxaliplatin, and Trifluridine/Tipiracil for Total Neoadjuvant Therapy in MSS Locally Advanced Low Rectal Cancer. This is a Non-Randomized, Single Group Assignment, Open Label, Phase: Phase II study. The Primary Objective is to assess the organ preservation rate (clinical complete response, cCR) after total neoadjuvant therapy. Secondary Objectives are Tumor regression grade (TRG), 3-year overall survival (OS) and disease-free survival (DFS), and Safety and quality of life (QoL). In this study, the investigators will perform the multi-dimensional omics study to explore the tumors microenvironments, explore the characteristics of the treatment benefit population, and try to construct an efficacy prediction model to screen the treatment benefit population early and implement precise treatment.
- Conditions
- Rectal Adenocarcinoma
- Being tested
- Pucotenlimab, Bevacizumab, Oxaliplatin, Trifluridine/Tipiracil Hydrochloride, Short-course radiotherapy
- Keywords
- Short-Course Radiotherapy, Pucotenlimab, Oxaliplatin, Bevacizumab, Trifluridine/Tipiracil（TAS-102）
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PucotenlimabDrug
Pucotenlimab (200 mg IV, q3w)
BevacizumabDrug
Bevacizumab (7.5 mg/kg IV, q3w)
OxaliplatinDrug
Oxaliplatin (130 mg/m² IV, q3w)
Trifluridine/Tipiracil HydrochlorideDrug
TAS-102 (25 mg/m² orally, days 1-5 and 8-12).
Short-course radiotherapyRadiation
(25 Gy/5 fractions)
intracavitary brachytherapyRadiation
brachytherapy (3 Gy/3 fractions).
| Study group | Role | What they receive |
|---|---|---|
| POBTAS Trial Arm | Experimental | Intervention:
1.Radiotherapy:
1. Phase 1 (Short-Course External Radiotherapy):
Intensity-modulated radiotherapy (IMRT) at 5 Gy X 5F, completed within 1 week.
2. Phase 2 (Intracavitary Brachytherapy):
Administered during weeks 5-6, targeting residual lesions with 3Gy X 3F, completed within 1 week.
2.Systemic Therapy Post-Initial Radiotherapy:
1. Cycles 1-2: PD-1 antibody immunotherapy (pucotenlimab) combined with bevacizumab, oxaliplatin, and trifluridine/tipiracil (TAS-102).
2. Cycles 3-4: Sequential PD-1 immunotherapy + oxaliplatin + TAS-102 (bevacizumab omitted in Cycle 4).
3.Post-Cycle 4 Evaluation: If ypT0 (local pathological complete response): Enter follow-up observation. If non-CR: Proceed to Step 4.
4.Extended Systemic Therapy for Non-CR Patients: Cycles 5-8: Repeat PD-1 immunotherapy + bevacizumab + oxaliplatin + TAS-102 (bevacizumab omitted in Cycle 8).
5.Post-Cycle 8 Evaluation: If ypT0: Enter follow-up observation. If non-ypT0: Proceed to TME surgery. Receives: Drug: Pucotenlimab; Drug: Bevacizumab; Drug: Oxaliplatin; Drug: Trifluridine/Tipiracil Hydrochloride; Radiation: Short-course radiotherapy; Radiation: intracavitary brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Organ preservation rate
The organ preservation rate was calculated as the percentage of participants who achieved cCR and were spared from total mesorectal excision (TME) surgery relative to the total study cohort. Clinical complete response (cCR) requires both histopathological confirmation (no viable tumor cells in biopsy specimens) and radiographic confirmation (absence of tumor on CT, MRI, or PET-CT).
Measured: Up to 2 weeks (once evaluation or biopsy is done)
Secondary outcomes (8)
Total mesorectal excision rate
Population who not achieve complete clinical response and have TME surgery 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: Through study completion, an average of 3 year
Tumor regression grade
Tumor Regression Grade（TRG）will be done via pathologic assessment on the surgical specimen with 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
Progression free survival
The proportion of participants who remain progression free at 3 years
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
Surgical Complications
Surgical Complications of biopsy, local excision or total mesorectal resection procedure for patients as assessed by Clavien-Dindo classification.
Measured: Up to 3 years
QoL
Quality of life of the patients in total neoadjuvant settings 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 posted12 Mar 2025
- Study start1 Apr 2025 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2028 (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.
- More trials run by Sir Run Run Shaw 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sir Run Run Shaw Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheng Dai, Sir Run Run Shaw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06872606
- Sponsor's protocol ID
- 2024-0623
- Acronym
- SCRIPBOT
- Status last verified
- Mar 2025
- First submitted
- 5 Mar 2025
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Short-Course Radiotherapy Combined with Intracavitary Brachytherapy Followed by Pucotenlimab, Bevacizumab, Oxaliplatin, and Trifluridine/Tipiracil (TAS-102) for Total Neoadjuvant Therapy of Microsatellite Stable (MSS) Locally Advanced Low Rectal Adenocarcinoma: an Prospective, Single Arm Clinical Trial （SCRIPBOT Trial）
- ClinicalTrials.gov ID
- NCT06872606
- Acronym / sponsor ID
- SCRIPBOT / 2024-0623
- Conditions
- Rectal Adenocarcinoma
- Keywords
- Short-Course Radiotherapy, Pucotenlimab, Oxaliplatin, Bevacizumab, Trifluridine/Tipiracil（TAS-102）
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Sir Run Run Shaw HospitalUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 12 Mar 2025 (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.
A Prospective Single-Arm Study of Short-Course Radiotherapy Followed by PD-1 Monoclonal Antibody, Bevacizumab, Oxaliplatin, and Trifluridine/Tipiracil for Total Neoadjuvant Therapy in MSS Locally Advanced Low Rectal Cancer. This is a Non-Randomized, Single Group Assignment, Open Label, Phase: Phase II study. The Primary Objective is to assess the organ preservation rate (clinical complete response, cCR) after total neoadjuvant therapy. Secondary Objectives are Tumor regression grade (TRG), 3-year overall survival (OS) and disease-free survival (DFS), and Safety and quality of life (QoL). In this study, the investigators will perform the multi-dimensional omics study to explore the tumors microenvironments, explore the characteristics of the treatment benefit population, and try to construct an efficacy prediction model to screen the treatment benefit population early and implement precise treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| POBTAS Trial Arm | Experimental | Drug: Pucotenlimab, Drug: Bevacizumab, Drug: Oxaliplatin, Drug: Trifluridine/Tipiracil Hydrochloride, Radiation: Short-course radiotherapy, Radiation: intracavitary brachytherapyIntervention: 1.Radiotherapy: 1. Phase 1 (Short-Course External Radiotherapy): Intensity-modulated radiotherapy (IMRT) at 5 Gy X 5F, completed within 1 week. 2. Phase 2 (Intracavitary Brachytherapy): Administered during weeks 5-6, targeting residual lesions with 3Gy X 3F, completed within 1 week. 2.Systemic Therapy Post-Initial Radiotherapy: 1. Cycles 1-2: PD-1 antibody immunotherapy (pucotenlimab) combined with bevacizumab, oxaliplatin, and trifluridine/tipiracil (TAS-102). 2. Cycles 3-4: Sequential PD-1 immunotherapy + oxaliplatin + TAS-102 (bevacizumab omitted in Cycle 4). 3.Post-Cycle 4 Evaluation: If ypT0 (local pathological complete response): Enter follow-up observation. If non-CR: Proceed to Step 4. 4.Extended Systemic Therapy for Non-CR Patients: Cycles 5-8: Repeat PD-1 immunotherapy + bevacizumab + oxaliplatin + TAS-102 (bevacizumab omitted in Cycle 8). 5.Post-Cycle 8 Evaluation: If ypT0: Enter follow-up observation. If non-ypT0: Proceed to TME surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 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.
- Clinical stage: cT2-4a N+ or cT3/T4a N0 (MRI/CT-confirmed).
Key exclusion criteria (15 listed)
- History of other malignant diseases in the past 5 years.
- Patients with metastases from other sites (stage IV patients).
- Patients withT4b or positive lateral lymph nodes by pelvic contrast-enhanced CT and pelvic high-resolution MRI.
- Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc. requiring emergency surgery.
- Known allergic to oxaliplatin, PD-1 monoclonal antibody and other intervention drugs.
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 |
|---|---|---|
| PucotenlimabPucotenlimab (200 mg IV, q3w) | Drug | POBTAS Trial Arm |
| BevacizumabBevacizumab (7.5 mg/kg IV, q3w) | Drug | POBTAS Trial Arm |
| OxaliplatinOxaliplatin (130 mg/m² IV, q3w) | Drug | POBTAS Trial Arm |
| Trifluridine/Tipiracil HydrochlorideTAS-102 (25 mg/m² orally, days 1-5 and 8-12). | Drug | POBTAS Trial Arm |
| Short-course radiotherapy(25 Gy/5 fractions) | Radiation | POBTAS Trial Arm |
| intracavitary brachytherapybrachytherapy (3 Gy/3 fractions). | Radiation | POBTAS Trial Arm |
Primary outcome
Organ preservation rate
Time frame: Up to 2 weeks (once evaluation or biopsy is done)
The organ preservation rate was calculated as the percentage of participants who achieved cCR and were spared from total mesorectal excision (TME) surgery relative to the total study cohort. Clinical complete response (cCR) requires both histopathological confirmation (no viable tumor cells in biopsy specimens) and radiographic confirmation (absence of tumor on CT, MRI, or PET-CT).
8 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: Through study completion, an average of 3 year
Tumor regression grade
Time frame: After 2 weeks (once biopsy or local excision is done)
Overall survival
Time frame: Up to 3 years
Progression free survival
Time frame: Up to 3 years
TRAEs
Time frame: Up to 3 years
Surgical Complications
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 12 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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 Pucotenlimab, Bevacizumab and Oxaliplatin 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 12 inclusion and 15 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: opening soon, as of the sponsor's last update on 12 Mar 2025. 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 (+86-13575472669, 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 preservation rate (time frame: Up to 2 weeks (once evaluation or biopsy 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 12 Mar 2025.