Rectal CancerPhase 2/3PKUCH-R09NCT06443671
Neoadjuvant Fruquintinib Plus Tislelizumab Combined With mCapeOX Versus CapeOX for Mid-high pMMR/MSS Locally Advanced Rectal Cancer
A Phase 2/3 study testing CapeOX and Fruquintinib and Tislelizumab combined with mCapeOX in people with Rectal Cancer, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if neoadjuvant Fruquintinib and Tislelizumab combined with mCapeOX works to treat mid-high pMMR/MSS locally advanced rectal cancer patients compared with CapeOX. It will also learn about the safety of neoadjuvant Fruquintinib and Tislelizumab combined with mCapeOX. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- CapeOX and Fruquintinib and Tislelizumab combined with mCapeOX
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2024to 1 Jun 2028
- Phase
- Phase 2/3
- 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
- The subjects voluntarily joined this study and signed an informed consent form;
- Age: 18-75 years old (including 18 and 75 years old), regardless of gender;
- Histologically confirmed rectal adenocarcinoma; Immunohistochemistry suggests pMMR, or PCR suggests MSS type patients;
- The tumor location meets the following criteria:
- Colonoscopy or digital examination shows that the distance from the lower edge of the tumor to the anus is 6-15cm or more than 4cm from the ARJ;
- MRI/CT determines that the lower edge of the tumor or the lower edge of the invading part is not higher than the sacral promontory pubic line;
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- Preoperative staging meets the following conditions:
- Preoperative staging of tumor infiltration breaking through the intestinal muscle layer (T3) or above or accompanied by periintestinal lymph node metastasis;
- Non invasion of the intrinsic fascia of the rectum (MRF -);
- No swelling observed in lateral lymph nodes (short diameter not exceeding 7mm)
- There is no clear evidence of distant metastasis, and R0 resection is expected to be feasible after treatment; *Baseline partial phase method: Rectal T2/DWI MR or Abdominal Pelvic CT or PET/CT or PET/MRI;
- Have not received any anti-tumor treatment for rectal cancer in the past, including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc;
- ECOG score: 0-1 points;
- Able to swallow tablets and capsules normally;
- The plan is to complete the entire process of neoadjuvant therapy and undergo surgical resection;
- The main organs and bone marrow function are basically normal (no blood components or cell growth factors were used within 14 days before enrollment):
- Blood routine: Neutrophils ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L, hemoglobin ≥ 90g/L;
- International standardized ratio (INR) ≤ 1.5 x Upper limit of normal value (ULN), and activated partial thromboplastin time (APTT) ≤ 1.5 x ULN;
- Liver function: Total bilirubin ≤ 1.5 x ULN, ALT/AST ≤ 2.5 x ULN；
- Renal function: serum creatinine ≤ 1.5 x ULN, and creatinine clearance rate (CCr) ≥ 50mL/min;
- Women of childbearing age must undergo a serum pregnancy test within 14 days before treatment, and the result is negative; Qualified patients with fertility (male and female) must agree to use reliable contraceptive methods (hormone or barrier methods or abstinence, etc.) with their partners during the trial period and at least 6 months after the last medication.
Who cannot join
- Have a history of allergies to any anti-angiogenic targeted drugs, any components of monoclonal antibodies, capecitabine, oxaliplatin, or other platinum-based drugs in the past;
- Preoperative evidence suggests distant metastasis (including lymph node metastasis in the iliac foramen area) Metastasis of aortic lymph nodes and retroperitoneal lymph nodes above the root level of IMA; In addition to clear liver lung metastasis, liver lung nodules with unknown properties should also be excluded;
- Symptoms of incomplete or complete intestinal obstruction; Or preoperative colonoscopy may indicate narrowing of the intestinal lumen circumference; Or if the tumor is too large, colonoscopy cannot pass through the tumor;
- Those who are currently using immunosuppressive agents, systemic or absorbable local hormone therapy to achieve immunosuppressive effects (dosage\>10mg/day prednisone or other therapeutic hormones), and continue to use them within 2 weeks prior to enrollment;
- Receive attenuated live vaccines within 4 weeks prior to the first use of the study drug;
- Any active autoimmune disease or history of autoimmune disease (such as but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or complete remission of childhood asthma in adulthood without any intervention can be included; subjects with asthma requiring medical intervention with bronchodilators cannot be included);
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- Other malignant tumors in the past 5 years (excluding skin basal cell or squamous cell carcinoma, cervical carcinoma in situ, breast cancer, thyroid papillary carcinoma and small kidney carcinoma that are clinically cured after proper treatment (OS\>5 years));
- Congenital or acquired immune deficiency (such as HIV infected persons), or active hepatitis (hepatitis B: HBsAg positive and HBV DNA ≥ 104 copies/ml; hepatitis C: HCV antibody positive and HCV RNA\>1 × 103 copies/ml);
- Have uncontrolled clinical symptoms or diseases of the heart, such as: (1) NYHA grade 2 or above heart failure; (2) Unstable angina pectoris; (3) Have experienced myocardial infarction within one year; (4) Clinically significant supraventricular or ventricular arrhythmias require treatment or intervention;
- Suffering from hypertension and unable to achieve good control through antihypertensive drug treatment (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg);
- Active or uncontrolled severe infections (≥ CTCAE level 2 infection);
- Urinary routine indicates that urine protein is ≥ 2+, and the 24-hour urine protein content is\>1.0g;
- Known genetic or acquired bleeding and thrombotic tendencies (such as hemophilia, coagulation dysfunction, thrombocytopenia, splenic hyperfunction, etc.) or undergoing thrombolytic or anticoagulant therapy;
- The patient currently has digestive tract diseases such as active gastric and duodenal ulcers, ulcerative colitis, or active bleeding from unresectable tumors, or other conditions determined by the researcher that may cause gastrointestinal bleeding or perforation;
- Patients with significant evidence of bleeding tendency or medical history within the 3 months prior to enrollment (bleeding\>30 mL within 3 months, vomiting blood, black stool, and rectal bleeding), hemoptysis (fresh blood\>5 mL within 4 weeks), or thromboembolic events (including stroke events and/or transient ischemic attacks) within 12 months;
- Pregnant (positive pregnancy test before medication) or breastfeeding women;
- According to the judgment of the researchers, the subjects may have other situations that may affect the results of the study or cause the study to be forced to stop midway, such as drug abuse, serious illnesses (including mental illnesses such as seizures), and other medical, psychological, or social conditions that may endanger patient safety and compliance.
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
Peking University Cancer Hospital & Institute
Beijing, Haidian District, 100142
Xiao Kang Lei, M.D., 108-819-6086, lxkpku@163.com
About this study
Official title: Neoadjuvant Fruquintinib Plus Tislelizumab Combined With mCapeOX Versus CapeOX for Mid-high pMMR/MSS Locally Advanced Rectal Cancer: A Prospective, Open-label, Multicenter, Randomized Controlled Trial
The goal of this clinical trial is to learn if neoadjuvant Fruquintinib and Tislelizumab combined with mCapeOX works to treat mid-high pMMR/MSS locally advanced rectal cancer patients compared with CapeOX. It will also learn about the safety of neoadjuvant Fruquintinib and Tislelizumab combined with mCapeOX. The main questions it aims to answer are:
- Does neoadjuvant Fruquintinib and Tislelizumab combined with mCapeOX improve the pCR rate of mid-high pMMR/MSS locally advanced rectal cancer patients?
- What medical problems do participants have when receiving neoadjuvant Fruquintinib and Tislelizumab combined with mCapeOX? Researchers will compare Fruquintinib and Tislelizumab combined with mCapeOX to CapeOX to see if neoadjuvant Fruquintinib and Tislelizumab combined with mCapeOX works to treat mid-high pMMR/MSS locally advanced rectal cancer patients.
Read more
Participants will:
- Receive Fruquintinib and Tislelizumab combined with mCapeOX or CapeOX before surgery up to 4 cycles
- Receive radical operations and three years follow-up
- Keep a diary of their postoperative pathology results and survival
- Conditions
- Rectal Cancer
- Being tested
- CapeOX, Fruquintinib and Tislelizumab combined with mCapeOX
- Keywords
- local advanced rectal cancer, neoadjuvant chemotherapy, pMMR/MSS, Furoquinib and Tislelizumab, CapeOX
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapeOXDrug
Receiving CapeOX treatment for up to four cycles before surgery:
Capecitabine: 1000mg/m2, BID, PO, D1-14, Q3W; Oxaliplatin: 130 mg/m2, intravenous drip for 0-2 hours, D1, Q3W.
Fruquintinib and Tislelizumab combined with mCapeOXDrug
Receiving Fruquintinib plus Tislelizumab combined with mCapeOX treatment for up to four cycles before surgery:
Fruquintinib: 3mg/d, QD, PO, Use for 2 weeks, stop for 1 week, Q3W; Tislelizumab: 200mg, D1, Intravenous infusion, Q3W; Capecitabine: 825mg/m2, BID, PO, D1-14, Q3W; Oxaliplatin: 100 mg/m2, intravenous drip for 0-2 hours, D1, Q3W.
| Study group | Role | What they receive |
|---|---|---|
| CapeOX group | Active comparator | Receiving CapeOX treatment for up to four cycles before surgery:
Capecitabine: 1000mg/m2, BID, PO, D1-14, Q3W; Oxaliplatin: 130 mg/m2, intravenous drip for 0-2 hours, D1, Q3W. Receives: Drug: CapeOX |
| Fruquintinib and Tislelizumab combined with mCapeOX | Experimental | Receiving Fruquintinib plus Tislelizumab combined with mCapeOX treatment for up to four cycles before surgery:
Fruquintinib: 3mg/d, QD, PO, Use for 2 weeks, stop for 1 week, Q3W; Tislelizumab: 200mg, D1, Intravenous infusion, Q3W; Capecitabine: 825mg/m2, BID, PO, D1-14, Q3W; Oxaliplatin: 100 mg/m2, intravenous drip for 0-2 hours, D1, Q3W. Receives: Drug: Fruquintinib and Tislelizumab combined with mCapeOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response(pCR) rates
Pathological complete response(pCR) rates are defined as no viable tumor cells remaining in the primary tumor and lymph nodes (ypT0N0), that is, subjects with level 0 of the AJCC 8th edition Tumor Regression Grading (TRG) scoring system proportion.
Measured: 10 days after surgery
Secondary outcomes (4)
Adverse events (AEs)
Adverse events (AEs) refer to adverse medical events that occur after clinical trial subjects receive a drug, but are not necessarily causally related to the treatment. AE can be any adverse and unexpected symptoms, signs, laboratory test abnormalities or diseases, etc., including at least the following situations: 1) Pre-existing medical conditions/diseases (before entering clinical trials) will be recorded as adverse events only if they worsen after starting to use the trial drug (including worsening of symptoms, signs, and laboratory test abnormalities); 2) Any new AE: any new adverse medical condition (including symptoms, signs, newly diagnosed diseases); 3) Abnormal clinically significant laboratory test results. Diagnostic or therapeutic invasive (such as surgery) and non-invasive procedures should not be reported as AEs, but when the disease condition that causes the procedures meets the definition of AE, they should be reported.
Measured: From the beginning to the 21st day after the end of neoadjuvant treatment
Major Pathologic Response(MPR)
MPR: The proportion of residual viable tumor cells in the postoperative specimen in the tumor bed is less than or equal to 10%.
Measured: 10 days after surgery
3-year event-free survival (EFS) rate
EFS is defined as the time from randomization to the occurrence of any of the following events, whichever occurs first: tumor disease progression on imaging as assessed by RECIST 1.1; tumor recurrence, including local recurrence or distant recurrence, as assessed on imaging or tissue biopsy transfer; death from any cause.
Measured: 36 months after randomization
3-year overall survival (OS) rate
OS is defined as the time between the date of randomization and death from any cause.
Measured: 36 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start1 Jun 2024 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06443671
- Sponsor's protocol ID
- PKUCH-R09
- Acronym
- PKUCH-R09
- Status last verified
- May 2024
- First submitted
- 30 May 2024
- Last updated
- 5 Jun 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 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Fruquintinib Plus Tislelizumab Combined With mCapeOX Versus CapeOX for Mid-high pMMR/MSS Locally Advanced Rectal Cancer: A Prospective, Open-label, Multicenter, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06443671
- Acronym / sponsor ID
- PKUCH-R09 / PKUCH-R09
- Conditions
- Rectal Cancer
- Keywords
- local advanced rectal cancer, neoadjuvant chemotherapy, pMMR/MSS, Furoquinib and Tislelizumab, CapeOX
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 5 Jun 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.
The goal of this clinical trial is to learn if neoadjuvant Fruquintinib and Tislelizumab combined with mCapeOX works to treat mid-high pMMR/MSS locally advanced rectal cancer patients compared with CapeOX. It will also learn about the safety of neoadjuvant Fruquintinib and Tislelizumab combined with mCapeOX. The main questions it aims to answer are:
- Does neoadjuvant Fruquintinib and Tislelizumab combined with mCapeOX improve the pCR rate of mid-high pMMR/MSS locally advanced rectal cancer patients?
- What medical problems do participants have when receiving neoadjuvant Fruquintinib and Tislelizumab combined with mCapeOX? Researchers will compare Fruquintinib and Tislelizumab combined with mCapeOX to CapeOX to see if neoadjuvant Fruquintinib and Tislelizumab combined with mCapeOX works to treat mid-high pMMR/MSS locally advanced rectal cancer patients.
Participants will:
- Receive Fruquintinib and Tislelizumab combined with mCapeOX or CapeOX before surgery up to 4 cycles
- Receive radical operations and three years follow-up
- Keep a diary of their postoperative pathology results and survival
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CapeOX group | Active comparator | Drug: CapeOXReceiving CapeOX treatment for up to four cycles before surgery: Capecitabine: 1000mg/m2, BID, PO, D1-14, Q3W; Oxaliplatin: 130 mg/m2, intravenous drip for 0-2 hours, D1, Q3W. |
| Fruquintinib and Tislelizumab combined with mCapeOX | Experimental | Drug: Fruquintinib and Tislelizumab combined with mCapeOXReceiving Fruquintinib plus Tislelizumab combined with mCapeOX treatment for up to four cycles before surgery: Fruquintinib: 3mg/d, QD, PO, Use for 2 weeks, stop for 1 week, Q3W; Tislelizumab: 200mg, D1, Intravenous infusion, Q3W; Capecitabine: 825mg/m2, BID, PO, D1-14, Q3W; Oxaliplatin: 100 mg/m2, intravenous drip for 0-2 hours, D1, Q3W. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- The subjects voluntarily joined this study and signed an informed consent form;
- Age: 18-75 years old (including 18 and 75 years old), regardless of gender;
- Histologically confirmed rectal adenocarcinoma; Immunohistochemistry suggests pMMR, or PCR suggests MSS type patients;
- The tumor location meets the following criteria:
- Preoperative staging meets the following conditions:
Key exclusion criteria (17 listed)
- Have a history of allergies to any anti-angiogenic targeted drugs, any components of monoclonal antibodies, capecitabine, oxaliplatin, or other platinum-based drugs in the past;
- Preoperative evidence suggests distant metastasis (including lymph node metastasis in the iliac foramen area) Metastasis of aortic lymph nodes and retroperitoneal lymph nodes above the root level of IMA; In addition to clear liver lung metastasis, liver lung nodules with unknown properties should also be excluded;
- Symptoms of incomplete or complete intestinal obstruction; Or preoperative colonoscopy may indicate narrowing of the intestinal lumen circumference; Or if the tumor is too large, colonoscopy cannot pass through the tumor;
- Those who are currently using immunosuppressive agents, systemic or absorbable local hormone therapy to achieve immunosuppressive effects (dosage\>10mg/day prednisone or other therapeutic hormones), and continue to use them within 2 weeks prior to enrollment;
- Receive attenuated live vaccines within 4 weeks prior to the first use of the study drug;
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 |
|---|---|---|
| CapeOXReceiving CapeOX treatment for up to four cycles before surgery: Capecitabine: 1000mg/m2, BID, PO, D1-14, Q3W; Oxaliplatin: 130 mg/m2, intravenous drip for 0-2 hours, D1, Q3W. | Drug | CapeOX group |
| Fruquintinib and Tislelizumab combined with mCapeOXReceiving Fruquintinib plus Tislelizumab combined with mCapeOX treatment for up to four cycles before surgery: Fruquintinib: 3mg/d, QD, PO, Use for 2 weeks, stop for 1 week, Q3W; Tislelizumab: 200mg, D1, Intravenous infusion, Q3W; Capecitabine: 825mg/m2, BID, PO, D1-14, Q3W; Oxaliplatin: 100 mg/m2, intravenous drip for 0-2 hours, D1, Q3W. | Drug | Fruquintinib and Tislelizumab combined with mCapeOX |
Primary outcome
Pathological complete response(pCR) rates
Time frame: 10 days after surgery
Pathological complete response(pCR) rates are defined as no viable tumor cells remaining in the primary tumor and lymph nodes (ypT0N0), that is, subjects with level 0 of the AJCC 8th edition Tumor Regression Grading (TRG) scoring system proportion.
4 secondary outcomes
Adverse events (AEs)
Time frame: From the beginning to the 21st day after the end of neoadjuvant treatment
Major Pathologic Response(MPR)
Time frame: 10 days after surgery
3-year event-free survival (EFS) rate
Time frame: 36 months after randomization
3-year overall survival (OS) rate
Time frame: 36 months after randomization
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 5 Jun 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing CapeOX and Fruquintinib and Tislelizumab combined with mCapeOX in people with Rectal Cancer, run by Peking University Cancer Hospital & Institute 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 21 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: opening soon, as of the sponsor's last update on 5 Jun 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Ai Wen Wu, M.D. (+8613911577190, wuaw@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response(pCR) rates (time frame: 10 days after surgery). 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 5 Jun 2024.