ClinicalTrials.gg
Status unknownNCT04715633Updated Jul 9, 2024

PD-1 Inhibitors Combined With VEGF Inhibitors for Locally Advanced dMMR/MSI-H Colorectal Cancer

A Phase 2 interventional study of PD-1 inhibitor plus VEGF inhibitors in Colorectal Cancer and Microsatellite Instability High, sponsored by Sun Yat-sen University. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-07-09.

Sponsored by Sun Yat-sen University · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2024), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
53
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

In this open-label phase II study, patients will be scheduled for neoadjuvant treatment with PD-1 inhibitors (Camrelizumab) plus VEGF inhibitor (Apatinib) for dMMR/MSI-H colorectal cancer staged as locally advanced (cT3-4N+/-M0 for rectal cancer, cT4 or cT3 with extramural extension ≥5mm for colon cancer). Radiological evaluation will be preformed after 4 cycles of treatment. Patients (either with colon or rectal cancer) who achieve complete clinical response will be offered the choice of Watch \& Wait.

Read the detailed description

This is an open-label phase II study, with the aim of determining the efficacy of PD-1 inhibitors (Camrelizumab) plus VEGF inhibitor (Apatinib) as a neoadjuvant therapy for dMMR/MSI-H locally advanced colorectal cancer.

Patients will be evaluated for eligibility within 14 days prior to study initiation with CT (for colon cancer) and/or MRI (for rectal cancer).

Patients will be given four cycles of Camrelizumab (200mg iv every 3 weeks) plus Apatinib (250mg QD day1-14) before being evaluated for response. For patients with colon cancer, if a SD/PD is achieved and the tumor is deemed unresectable, they will be offered chemotherapy±radiotherapy, while if a CR or PR is achieved, they will be offered another four cycles of Camrelizumab + Apatinib. After completing 8 cycles of treatment, if a CR is achieved they will be offered the choice of Watch \& Wait. For patients with rectal cancer who have a SD/PD (after 4 cycles), chemoradiotherapy will be offered, while for those with a CR/PR, another four cycles of the treatment will be given. After completing 8 cycles of treatment, if a CR is achieved patients will be offered the choice of Watch \& Wait.

02

Conditions studied

  • Colorectal Cancer
  • Microsatellite Instability High
03

In context

Colorectal Neoplasms

5,734 studies on the registry are indexed under Colorectal Neoplasms; 1,481 are open to participants now.

This study's enrollment of 53 is below the median of 77 across 4,222 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,680 studies on the registry; 609 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Locally confirmed dMMR or MSI-H colorectal carcinoma
  • Tumor staging based on CT/MR or transrectal ultrasound imaging:
  • Colon cancer: radiological high risk (rT4 or rT3 tumour with extramural extension ≥ 5mm with or without lymph node involvement)
  • Rectal cancer: \<12 cm from the anal verge and radiological high risk (rT3/4 with or without lymph node involvement)
  • No sign of bowel obstruction, or bowel obstruction has been relieved by ostomy
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 10 days prior to study start
  • Aged 18 or over
  • Life expectancy of at least 2 years
  • Measurable disease
  • Female participants of childbearing potential must be willing to use adequate contraception for the course of the study starting with the first dose of study medication through 120 days after the last PD-1 antibody dose
  • Male participants must agree to use adequate contraception for the course of the study starting with the first dose of study medication through 120 days after the last PD-1 antibody dose
  • Adequate organ function

Exclusion criteria

Exclusion Criteria:

  • Active autoimmune disease that has required systemic treatment in past 2 years
  • Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 2 weeks prior to this study start
  • Currently participating and receiving treatment in another study within 4 weeks of study start
  • History of severe allergic reaction to monoclonal antibody
  • Strong evidence of distant metastases or peritoneal nodules (M1)
  • Colonic obstruction that has not been defunctioned
  • Has received prior therapy with an immune checkpoint inhibitor (e.g., anti-programmed cell death [PD]-1, anti-PD ligand 1 [L1], anti-PD-L2 agent, or anti-cytotoxic T-lymphocyte-associated protein 4 [CTLA-4] agent, etc.) or anti-VEGF agents (e.g., Bevacizumab, Apatinib)
  • Any other malignant disease within the preceding 5 years with the exception of non-melanomatous skin cancer, carcinoma in situ and early stage disease with a recurrence risk \<5%
  • Received a live vaccine within 30 days of planned start of study medication
  • Known history of Human Immunodeficiency Virus (HIV), Hepatitis B or C
  • Known history of, or any evidence of interstitial lung disease or active, non-infectious pneumonitis
  • Known history of active tuberculosis (Bacillus tuberculosis [TB])
  • Active infection requiring systemic therapy
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
53 participants (actual)

Study arms

  • Experimental
    PD-1 inhibitors plus VEGF inhibitors

    Patients will be given 4 cycles of Camrelizumab (200mg iv every 3 weeks) plus Apatinib (250mg QD day1-14) before being evaluated for response.

    Drug: PD-1 inhibitor plus VEGF inhibitors

Interventions

  • DrugPD-1 inhibitor plus VEGF inhibitors

    Drug pages: Camrelizumab · Apatinib

    Camrelizumab 200mg IV every 3 weeks; Apatinib 250mg QD day 1-14. Rescue chemotherapy: Oxaliplatin 130mg/m2 IV drip Q3W d1+Capecitabine 1000mg/m2 QD d1-d14 Rescue chemoradiotherapy: Long-course radiotherapy +Capecitabine 825mg/m2 QD d1-d14

    Also known as: Camrelizumab plus Apatinib

06

What researchers measure

Primary outcomes

  1. Clinical complete response or pathological complete response

    Clinical complete response or immunotherapy-related pathological complete response (cCR or immunotherapy-related pCR)

    Time frame: up to 2 year

Secondary outcomes

  1. Objective Response Rate (ORR, PR+CR)

    Partial response + complete response

    Time frame: up to 2 year

  2. 3-year relapse-free survival

    Time frame: up to 3 years

  3. 3-year overall survival

    Time frame: up to 3 years

  4. Surgical complications

    Time frame: within 1 month after surgery

  5. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Time frame: up to 2 year

07

Study locations

1 site
  • 651 Dongfeng Road East
    Guangzhou, Guangdong 510060, China
08

References and documents

Publications

  • Yu JH, Xiao BY, Li DD, Jiang W, Ding Y, Wu XJ, Zhang RX, Lin JZ, Wang W, Han K, Kong LH, Zhang XK, Chen BY, Mei WJ, Pan ZZ, Tang JH, Zhang XS, Ding PR. Neoadjuvant camrelizumab plus apatinib for locally advanced microsatellite instability-high or mismatch repair-deficient colorectal cancer (NEOCAP): a single-arm, open-label, phase 2 study. Lancet Oncol. 2024 Jul;25(7):843-852. doi: 10.1016/S1470-2045(24)00203-1. Epub 2024 Jun 6. PubMed 38852601 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04715633
Collaborators
Guangdong Provincial People's Hospital, Guangdong Provincial Hospital of Traditional Chinese Medicine
Responsible party
Pei-Rong Ding (Professor, Sun Yat-sen University) — Principal investigator
First posted
Jan 20, 2021
Start date
Dec 1, 2020
Primary completion
Aug 30, 2023
Completion
Jul 31, 2025 (estimated)
Last update
Jul 9, 2024

Study contacts

Pei-Rong Ding, M.D.
principal investigator · Sun Yat-sen University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Camrelizumab · Apatinib

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