TislelizumabPhase 2NCT05970302

XELOX +Bev +Tislelizumab for First-line Treatment of MSS/pMMR RAS-mutated mCRC

A Phase 2 study testing Tislelizumab+Bevacizumab+Oxaliplatin+Capecitabine in people with Tislelizumab and Bevacizumab, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Tislelizumab, Bevacizumab, Oxaliplatin
What is being tested?: Tislelizumab+Bevacizumab+Oxaliplatin+Capecitabine
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 52 participants
Where: 1 siteChina
Study dates: 7 Jul 2023to Jul 2026
Phase: Phase 2
Are there results?: None posted in the registry

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

Histologically confirmed initially unresectable MSS/pMMR-type RAS-mutant metastatic colorectal adenocarcinoma;
ECOG score of 0 or 1;
Ability to swallow oral medications;
Have at least one measurable lesion (according to RECIST v1.1 standard);
No anti-tumor treatment has been received after recurrence and metastasis;
Neoadjuvant or adjuvant chemotherapy containing fluorouracil drugs is allowed before or after radical resection of colorectal cancer, but the treatment needs to be completed for ≥ 6 months; if oxaliplatin is used in neoadjuvant or adjuvant chemotherapy, it includes The oxaliplatin regimen needs to be completed for ≥12 months;

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Adequate organ function: On the premise of no component blood transfusion within 14 days: white blood cells ≥ 3.5*10^9/L and neutrophils ≥ 1.5*10^9/L, hemoglobin ≥ 90g/L, platelets ≥ 100* 10^9/L; serum bilirubin ≤ 1.5 times the normal value, alanine aminotransferase (ALT) ≤ 2.5 times the normal value, aspartate aminotransferase (AST) ≤ 2.5 times the normal value; Urinary protein <2+. Or urine protein 2+ but 24-hour urine protein quantity ≤ 1 g; serum creatinine ≤ 1.5 times of normal value, creatinine clearance rate ≥ 60ml/min; Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) ≥ lower limit of normal value (50%);
Expected survival period ≥ 3 months;
Patients fully understand this research, voluntarily participate in this clinical trial and sign an informed consent;
Women with reproductive potential (< 2 years after the last menstrual period) and men use effective contraceptive methods until half a year after the last treatment.

Who cannot join

Previously received bevacizumab or anti-CTLA4, anti-PD-1/PD-L1 therapeutic antibodies or pathway-targeted drugs;
Received radiotherapy within 4 weeks before the evaluation;
Symptomatic peripheral neuropathy > grade 2 (CTCAE5.0 standard);
Received live vaccine or systemic immune stimulant (including but not limited to interferon or interleukin 2) within 1 month;
HIV-positive and other immunodeficiency diseases;
Active hepatitis B or hepatitis C (except for those who have been infected or cured before, that is, HBsAg negative and hepatitis B core antigen anti-HBc antibody positive; except for hepatitis C patients whose HCV RNA is negative by PCR);

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Existing autoimmune diseases or other diseases that require immunosuppressant treatment, except for type 1 diabetes; except for hypothyroidism that only requires hormone replacement therapy; skin diseases that do not require systemic treatment (such as vitiligo, psoriasis, alopecia areata); inhaled or topical steroids or equivalent steroids in excess of 10 mg prednisone per day, except for inactive autoimmune disease on adrenal replacement therapy;
Received systemic hormone therapy or treatment with a daily dose of more than 10 mg prednisone equivalent dose or other forms of immunosuppressive treatment within 7 days, but inhaled or topical steroids or daily application of more than 10 mg prednisone, etc. Except for inactive autoimmune diseases treated with adrenal replacement therapy with potent steroids;
Have a history of organ transplantation;
Uncontrolled central nervous system (CNC) metastasis (symptomatic or metastatic sites are midbrain, pons, medulla or spinal cord) or other central nervous system diseases;
Those who have undergone major surgery, open biopsy or obvious traumatic trauma within 1 month, or who may need major surgery during the study period; those who have undergone open biopsy or obvious traumatic trauma, or may need major surgery during the study period;
Combined with other malignant tumors other than intestinal cancer (except cured basal cell carcinoma or squamous cell carcinoma of the skin and carcinoma in situ of the cervix; the treatment of other malignant tumors has been completed for more than 1 year, and there is no clinical and imaging evidence of recurrence or progression except);
Combined active and refractory infection;
Cardiovascular diseases with clinical significance, such as cardiovascular accident (CVA) (≤ 6 months before treatment), myocardial infarction (≤ 6 months before treatment), unstable angina, chronic heart failure of NYHA ≥ 2 (CHF), uncontrolled arrhythmia; uncontrolled hypertension; thromboembolic or bleeding events within 6 months before treatment;
Evidence of causing coagulation disease;
With dysphagia, active peptic ulcer, complete or incomplete intestinal obstruction, active gastrointestinal bleeding, perforation, malabsorption syndrome or uncontrollable gastrointestinal inflammatory disease (such as Crohn's disease or ulcerative colon inflammation);
Severe unhealed wounds/ulcers or severe fractures;
Any serious acute or chronic medical condition that may affect the patient's participation in the study or interfere with the interpretation of the study results;
There are mental illnesses, serious social and psychological illnesses, or researchers believe that there are factors that may affect research compliance;
Pregnant or lactating women;
No therapeutic anticoagulant or antiplatelet drugs or NSAIDs (aspirin ≤ 325 mg/day allowed);
Severe allergic reaction to the test drug;
Reluctance to use alternative therapies such as (but not limited to) bisphosphonates if receiving RANKL inhibitors (eg, denosumab).

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

Lin Yang
Beijing
lin yang, 13611267380, linyangcicams@126.com
Recruiting

Other trials in China

About this study

Official title: XELOX and Bevacizumab in Combination With Tislelizumab for First-Line Treatment of Patients With MSS/pMMR RAS-mutated Metastatic Colorectal Cancer (mCRC): A Single-arm, Phase II Study.

The goal of this clinical trial is to compare XELOX +Bev +Tislelizumab with standard chemotherapy，in MSS/pMMR-type RAS-mutated metastatic colorectal adenocarcinoma. The main questions it aims to answer are efficacy and safety of the regimen of XELOX +Bev +Tislelizumab. The investigators want to transform ras-mutated colorectal cancer into a "hot tumor" through the combination of anti-vascular therapy and chemotherapy, and then achieve better therapeutic effect through the combination with immunotherapy. Participants will receive the regimen of XELOX +Bev +Tislelizumab.

Conditions: Tislelizumab, Bevacizumab, Oxaliplatin, Capecitabine, MSS/pMMR, Metastatic Colorectal Cancer (mCRC)
Being tested: Tislelizumab+Bevacizumab+Oxaliplatin+Capecitabine
Keywords: Single-arm, Phase II
Medical subject headings: Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tislelizumab+Bevacizumab+Oxaliplatin+CapecitabineDrug
Use the above medications on a regular basis.

Study groups in NCT05970302
Study group	Role	What they receive
XELOX +Bev +Tislelizumab	Experimental	Every 3 weeks as a cycle: 1. Tislelizumab: 200mg, iv, d1; 2. Bevacizumab: 7.5mg/kg, iv, d1; 3. Oxaliplatin: 130mg/m2, iv, d1; 4. Capecitabine: 1000mg/m2, bid, po, d1-d14; Re-evaluate patients every two cycles. If the patient has been treated for more than 8 cycles, they will enter maintenance therapy, and the regimen is capecitabine + BEV combined with tislelizumab. Receives: Drug: Tislelizumab+Bevacizumab+Oxaliplatin+Capecitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

Objective Response Rate (ORR)
ORR of regimen of XELOX +Bev +Tislelizumab
Measured: 2 years

Secondary outcomes (6)

Duration of Response (DoR)
Measured: 2 years
Disease Control Rate (DCR);
Measured: 2 years
Median Progression-Free Survival (mPFS)
Measured: 2 years
12-month PFS rate
Measured: 12 months
Median Overall Survival (mOS)
Measured: 5 years
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Adverse Events (AEs) Incidence, Serious Adverse Events (SAE) Incidence
Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Jul 2023Jul 2026

First posted1 Aug 2023
Study start7 Jul 2023
Primary completionJul 2025 (estimated)
Study completionJul 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for TislelizumabStudies of the same condition, open and under way.
More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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: 52 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05970302
Sponsor's protocol ID: NCC-009591
Status last verified: Jul 2023
First submitted: 6 Jul 2023
Last updated: 1 Aug 2023
Results posted: No
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 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: XELOX and Bevacizumab in Combination With Tislelizumab for First-Line Treatment of Patients With MSS/pMMR RAS-mutated Metastatic Colorectal Cancer (mCRC): A Single-arm, Phase II Study.
ClinicalTrials.gov ID: NCT05970302
Acronym / sponsor ID: NCC-009591
Conditions: Tislelizumab, Bevacizumab, Oxaliplatin, Capecitabine, MSS/pMMR, Metastatic Colorectal Cancer (mCRC)
Keywords: Single-arm, Phase II
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 52 participants (estimated)
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
Study start: 7 Jul 2023 (actual)
Primary completion: Jul 2025 (estimated)
Study completion: Jul 2026 (estimated)
First posted: 1 Aug 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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
XELOX +Bev +Tislelizumab	Experimental	Drug: Tislelizumab+Bevacizumab+Oxaliplatin+CapecitabineEvery 3 weeks as a cycle: 1. Tislelizumab: 200mg, iv, d1; 2. Bevacizumab: 7.5mg/kg, iv, d1; 3. Oxaliplatin: 130mg/m2, iv, d1; 4. Capecitabine: 1000mg/m2, bid, po, d1-d14; Re-evaluate patients every two cycles. If the patient has been treated for more than 8 cycles, they will enter maintenance therapy, and the regimen is capecitabine + BEV combined with tislelizumab.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Histologically confirmed initially unresectable MSS/pMMR-type RAS-mutant metastatic colorectal adenocarcinoma;
ECOG score of 0 or 1;
Ability to swallow oral medications;
Have at least one measurable lesion (according to RECIST v1.1 standard);
No anti-tumor treatment has been received after recurrence and metastasis;

Key exclusion criteria (23 listed)

Previously received bevacizumab or anti-CTLA4, anti-PD-1/PD-L1 therapeutic antibodies or pathway-targeted drugs;
Received radiotherapy within 4 weeks before the evaluation;
Symptomatic peripheral neuropathy > grade 2 (CTCAE5.0 standard);
Received live vaccine or systemic immune stimulant (including but not limited to interferon or interleukin 2) within 1 month;
HIV-positive and other immunodeficiency diseases;

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
Tislelizumab+Bevacizumab+Oxaliplatin+CapecitabineUse the above medications on a regular basis.	Drug	XELOX +Bev +Tislelizumab

Primary outcome

Objective Response Rate (ORR)
Time frame: 2 years
ORR of regimen of XELOX +Bev +Tislelizumab

6 secondary outcomes

Duration of Response (DoR)
Time frame: 2 years
Disease Control Rate (DCR);
Time frame: 2 years
Median Progression-Free Survival (mPFS)
Time frame: 2 years
12-month PFS rate
Time frame: 12 months
Median Overall Survival (mOS)
Time frame: 5 years
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: 2 years

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
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. This study is not recruiting at the moment.

Lin Yang

Beijing, China

13611267380

linyangcicams@126.com

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 23 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: status not confirmed, as of the sponsor's last update on 1 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05970302.

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 1 Aug 2023.