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Metastatic Colorectal Cancer (CRC)Phase 2/3NCT06959693

A Clinical Study to Evaluate the Efficacy and Safety of Envafolimab Combined With Cetuxima-βand mFOLFOX6 in Patients With MSS, RAS/BRAF Wild-Type Metastatic Colorectal Cancer (mCRC)

A Phase 2/3 study testing Cetuxima-β, Envafolimab and mFOLFOX6 in people with Metastatic Colorectal Cancer (CRC), run by Sun Yat-sen University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This is a prospective randomized controlled Phase Ⅱ/Ⅲ Clinical study to evaluate the clinical efficacy and safety of Envafolimab combining with Cetuximab -β and mFOLFOX6 in Patients With MSS, RAS/BRAF Wild-Type Metastatic Colorectal Cancer (mCRC) Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Colorectal Cancer (CRC)
What is being tested?
Cetuxima-β, Envafolimab and mFOLFOX6
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
590 participants
Where
1 siteChina
Study dates
1 Jun 2025to 30 Jun 2030
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients are eligible for the study if they meet all of the following criteria:
  • Prior to enrollment, the participant is required to sign a written informed consent form.
  • Participants should be above 18 years，regardless of gender.
  • Histopathologically confirmed untreated advanced colorectal adenocarcinoma.
  • Tumors with RAS (KRAS, NRAS, HRAS) and BRAF wild-type, MSS phenotype, excluding appendiceal or anal cancer. All listed codons must be wild-type: KRAS: Exons 2, 3, 4 (Codons 12, 13, 59, 61, 117, 146) ; NRAS: Exons 2, 3, 4 (Codons 12, 13, 59, 61, 117, 146)
  • Imaging (enhanced CT/MRI/PET-CT) confirms advanced/metastatic colorectal cancer with measurable lesions according to RECIST v1.1.
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  • No prior systemic therapy for advanced/metastatic colorectal cancer, including chemotherapy, EGFR inhibitors (cetuximab, panitumumab), VEGF inhibitors (bevacizumab), and immune checkpoint inhibitors (anti-PD-1/PD-L1/CTLA-4). Adjuvant/neoadjuvant chemotherapy within 6 months before recurrence/metastasis is considered first-line therapy.
  • ECOG PS score 0-1.
  • Expected survival >12 weeks.
  • Adequate organ function (without blood component or growth factor use within 14 days):
  • Hematology:Neutrophils ≥1.5×10⁹/L, platelets ≥100×10⁹/L, hemoglobin ≥90 g/L. Liver/kidney function: SCr ≤1.5×ULN or creatinine clearance ≥50 ml/min, TBIL ≤1.5×ULN, AST/ALT ≤2.5×ULN (≤5×ULN if due to liver metastasis), urine protein <2+ (≤1g/24h if ≥2+).
  • Normal coagulation, no active bleeding/thrombosis: INR ≤1.5×ULN, APTT ≤1.5×ULN, PT ≤1.5×ULN.
  • Non-surgically sterile women of childbearing potential must use contraception during and 3 months after treatment; serum/urine HCG negative within 7 days before enrollment; not breastfeeding. Non-surgically sterile men must use contraception with partners during and 3 months after treatment.
  • Willing participant with good compliance for safety and survival follow-up.

Who cannot join

  • -
  • Patients will be excluded from the study if they meet any of the following exclusion criteria:
  • Other malignancies in the past or current (excluding cured basal cell carcinoma or cervical carcinoma in situ).
  • Current duodenal ulcer, ulcerative colitis, intestinal obstruction, or other GI conditions that may cause bleeding or perforation, as judged by the investigator.
  • Patients with symptomatic pleural, peritoneal, or pericardial effusions requiring treatment.
  • History of allergy to monoclonal proteins or any component of the study drugs.
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  • Oral traditional Chinese medicine, immunomodulators within 2 weeks, or radiotherapy within 4 weeks before treatment.
  • Thyroid dysfunction that is uncontrolled by medication.
  • Uncontrolled hypertension despite receiving optimal treatment (systolic BP>150 mmHg or diastolic BP>90 mmHg).
  • Uncontrolled cardiac conditions: (1) NYHA Class II+ heart failure; (2) unstable angina; (3) myocardial infarction within 1 year; (4) clinically significant arrhythmias requiring treatment.
  • Active autoimmune disease or a history of such diseases.
  • Immunosuppressants, systemic, or absorbable topical steroids for immunosuppression (>10 mg/day prednisone or equivalent) within 2 weeks before enrollment.
  • CNS metastases.
  • Active infection or unexplained fever>38.5°C during screening or before first dose (tumor-related fever is acceptable).
  • History or current evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-induced pneumonia, or severe pulmonary dysfunction.
  • Congenital or acquired immunodeficiency, such as HIV infection, or active hepatitis (elevated transaminases not meeting inclusion criteria, HBV DNA≥1000 IU/ml, HCV RNA≥1000 IU/ml).
  • Live vaccine administration within 4 weeks before first dose or planned during the study.
  • History of psychiatric drug abuse, alcoholism, or drug addiction.
  • Pregnant or breastfeeding women, or those planning pregnancy during the trial.
  • Any other factor that may lead to premature study discontinuation, as judged by the investigator.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ruihua Xu, PhD contact

+86-13922206676

xurh@sysucc.org.cn

China1 site

  • Medical Oncology,Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510075

    Feng Wang, PhD, +86-020-87343009, lunli@sysucc.org.cn

Other trials in China

About this study

Official title: mFOLFOX and Cetuximab - β With or Without Envafolimab for MSS, RAS/BRAF Wild - Type Advanced Unresectable CRC: Prospective, Randomized, Controlled Phase Ⅱ/Ⅲ Trial

This is a prospective randomized controlled Phase Ⅱ/Ⅲ Clinical study to evaluate the clinical efficacy and safety of Envafolimab combining with Cetuximab -β and mFOLFOX6 in Patients With MSS, RAS/BRAF Wild-Type Metastatic Colorectal Cancer (mCRC)

Read the detailed description

Patients diagnosed with unresectable, microsatellite - stable (MSS), RAS/BRAF wild - type metastatic colorectal adenocarcinoma who have not received prior systemic anti-neoplastic therapy for metastatic or recurrent lesions will be included in this study.

In the Phase II study, approximately 186 patients will be enrolled, with 93 assigned to the experimental group and 93 to the control group. In the Phase III study, around 404 patients will be recruited, with 202 allocated to the experimental group and 202 to the control group.

Eligible patients will undergo a screening period of up to 28 days, followed by a treatment period consisting of 2 - week cycles for a maximum duration of 2 years. Subsequently, a follow - up period will be implemented, which includes a safety follow - up and survival follow - ups conducted every 12 weeks.

Being tested
Cetuxima-β, Envafolimab, mFOLFOX6
Medical subject headings
Colorectal Neoplasms

What participants receive

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

  • Cetuxima-βDrug

    500 mg/m², initial intravenous infusion (IV)>120 min, subsequent IV >60 min , D1，every 2 weeks

  • EnvafolimabDrug

    a single fixed dose of 200 mg, subcutaneous injection(SC), every 2 weeks (Day 1 of each cycle [D1])

  • mFOLFOX6Drug

    Oxaliplatin 85 mg/m² , IV, over 120 min, Day 1; Leucovorin 400 mg/m² (or Calcium Folinate 200 mg/m²), IV, over 120 min, D1; 5-FU 400 mg/m² , bolus injection, followed by 1200 mg/(m²·d) continuous IV for 2 days (total dose 2400 mg/m² over 46 - 48 hours)

Study groups in NCT06959693
Study groupRoleWhat they receive
Envafolimab combining with Cetuximab -β and mFOLFOX6ExperimentalNot described
Receives: Drug: Cetuxima-β; Drug: Envafolimab; Drug: mFOLFOX6
Cetuximab -β and mFOLFOX6Active comparatorNot described
Receives: Drug: Cetuxima-β; Drug: mFOLFOX6

What is being measured

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

  1. Progressin Free Survival，PFS

    Progression-free survival based on RECIST v1.1

    Measured: Time Frame: from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 3 years

Secondary outcomes (5)

  1. OS，Overall survival

    Measured: from the date of first dose unitl the date of death from any cause，assessed up to 3 years

  2. ORR， Objective response

    Objective response rate based on RECIST v1.1

    Measured: up to 3 years

  3. DCR， Disease control rate

    the proportion of patients with the best overall response of CR, PR, or stable disease (SD)

    Measured: up to 1 year

  4. NED Rate， No Evidence of Disease Rate

    The proportion of participants with no evidence of disease after treatment, as determined by current assessments (pathological, imaging, and molecular biology). NED includes complete response (CR), R0 resection, or other local treatments, such as radiofrequency, microwave, or cryoablation (which can be combined with surgery), that eliminate the tumor.

    Measured: up to 3 years

  5. Safety(Adverse Event (AE) Incidence)

    Adverse Event (AE) Incidence

    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.

  1. First posted6 May 2025
  2. Study start1 Jun 2025 (estimated)
  3. Primary completion30 Sep 2028 (estimated)
  4. Study completion30 Jun 2030 (estimated)

Resources

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
Model description
Experimental Arm: Cetuximab β + mFOLFOX6 + Envafolimab • Induction Phase (12 cycles): o Patients receive cetuximab β + mFOLFOX6 + envafolimab. o Patients who achieve CR/PR/SD (no disease progression) after 12 cycles proceed to the maintenance phase. • Maintenance Phase: o Cetuximab β + 5-FU + envafolimab Control Arm: Cetuximab β + mFOLFOX6 • Induction Phase (12 cycles): o Patients receive cetuximab β + mFOLFOX6. o Patients who achieve CR/PR/SD (no disease progression) after 12 cycles proceed to the maintenance phase. • Maintenance Phase: o Cetuximab β + 5-FU
Masking
None (open label)
Enrolment
590 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06959693
Sponsor's protocol ID
SMA CRC 005
Status last verified
Apr 2025
First submitted
28 Apr 2025
Last updated
6 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Cetuxima-β, Envafolimab and mFOLFOX6 in people with Metastatic Colorectal Cancer (CRC), run by Sun Yat-sen University 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 14 inclusion and 20 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 6 May 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 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 Ruihua Xu, PhD (+86-13922206676, xurh@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progressin Free Survival，PFS (time frame: Time Frame: from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 3 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 NCT06959693.

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 6 May 2025.

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