Chemotherapy and Immunotherapy as Treatment for MSS Metastatic Colorectal Cancer With High Immune Infiltrate (POCHI)

August 16, 2023 updated by: Federation Francophone de Cancerologie Digestive

Pembrolizumab in Combination With Xelox Bevacizumab in Patients With Microsatellite Stable Mestatic Colorectal Cancer and a High Immune Infiltrate : a Proof of Concept Study

About 85% of cases of non-metastatic colorectal cancer (CRC) are related to chromosomal instability and have a proficient DNA Mismatch-Repair system (pMMR); which are also called CRC with microsatellite stability (MSS). Other CRC, i.e. 15%, are "microsatellite unstable" (MSI) with deficient DNA Mismatch-Repair system (dMMR). These latter are characterised by generation of many neo-antigens, which result in a high anti-tumour immune response and a high peri- and/or intra-tumour lymphocyte infiltration (TIL). Investigators recently showed, with a prospectively validated immune score, that 14% of localised MSS/pMMR CRC are also highly infiltrated by CD3+ lymphocytes. This same immune score has made it possible to measure high lymphocyte infiltration in hepatic metastases, in particular, in patients treated with XELOX/FOLFOX.

Pembrolizumab, an anti-PD1 monoclonal antibody (programmed death-1) is an immune checkpoint inhibitor (ICI) of PD1/PD-L1 axis, recently approved in many cancers. Anti-PD1 antibodies have recently been reported as being very effective in patients with dMMR metastatic CRC (mCRC). In the study by Le DT et al. pMMR mCRC did not seem to benefit from anti-PD1 antibodies. However, it is possible that 20% of pMMR mCRC with a high CD3+ infiltrate in the tumour may be a subgroup of pMMR mCRC sensitive to ICI, as is the case for dMMR mCRC. Lastly, immunogenic cell death induced by chemotherapy, such as oxaliplatin, can increase the efficacy of ICI.

The prognostic value of lymphocyte infiltrate has been demonstrated in CRC by several teams. However, no validated test is used in routine clinical practice. Previously, investigators described an automated and reproducible method for analysis of TIL and investigators validated it for clinical use. Automated tests evaluating TIL are performed on virtual slides and have showed that, out of 1,220 tumours tested, 20% were highly infiltrated by CD3+ T cells. Patients presenting with a pMMR CRC with a high immune infiltrate had a better progression-free survival (HR=0.70; p=0.02). An immunoscore® described by Galon et al. has also a high prognostic value in CRC and is based on CD3+ and CD8+ T cells infiltration in the center and periphery of the tumour. Finally, approximately 14% of tumours with a high immune infiltrate have been found in patients with metastatic CRC.

Investigators formulated the hypothesis that patients with a pMMR CRC with a high immune infiltrate can be sensitive to ICI . Therefore, blocks of resected primary tumour will be collected and analysed prospectively. For each patient, slides containing tumour tissue and adjacent non-tumour tissue will be analysed using two techniques : immunoscore® and TuLIS score.It consist in Immunohistochemistry with CD3 and CD8 staining. Slides will be scanned and analysed by image analysis as previously described . Tumours will then be classified as having a "high" or "low" immune response according to type of lymphocyte infiltrate, which is independent of pre-analytic conditions. Only patients with a high immune response will be eligible for the POCHI trial. Other biomarkers will be analysed like other immune populations or mutational load. If investigators identify an immune score which seems clinically relevant to predict sensitivity to ICI in pMMR mCRC, this will make it possible to plan a randomised phase III trial comparing chemotherapy and anti-angiogenic antibody versus chemotherapy and anti-angiogenic antibody plus pembrolizumab in patients with a pMMR mCRC with a high immune score and/or a hypermutated genotype.

Investigators choose PFS at 10 months as primary endpoint in POCHI trial because it is a surrogate marker of OS. Actually median PFS in first-line setting with a doublet plus a biological agent is range from 8 to 11 months in unresectable mCRC, corresponding to a PFS of 50% at 10 months. The alternative clinical hypothesis to obtain 70% of patients alive and without progression at 10 months is ambitious and currently not achieved with current chemotherapies plus a biological agent. Up until now there is no data concerning survivals outcomes of patients with a MSS mCRC with high immune infiltration score.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

55

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Abbeville, France, 80090
      • Amiens, France
      • Amiens, France
      • Angers, France, 49055
      • Annemasse, France, 74100
        • Not yet recruiting
        • Privé - Hôpital Privé Pays de Savoie
        • Contact:
        • Contact:
        • Principal Investigator:
          • Wulfran CACHEUX, Dr
      • Antony, France, 92160
        • Recruiting
        • Privé - Hôpital Privé D'Antony
        • Contact:
        • Contact:
        • Principal Investigator:
          • Anne THIROT BIDAULT, Dr
      • Avignon, France, 84902
        • Recruiting
        • Ch - Hôpital Henri Duffaut
        • Contact:
        • Contact:
        • Principal Investigator:
          • Thibault BROTELLE, Dr
      • Avignon, France
        • Recruiting
        • Prive - Institut Du Cancer Avignon Provence
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Rania BOUSTANY-GRENIER
        • Sub-Investigator:
          • Laurent MINEUR
      • Bayonne, France
        • Not yet recruiting
        • Privé - Clinique Capio Balharra
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marjorie FAURE, Dr
      • Bayonne CEDEX, France, 64100
        • Recruiting
        • Ch - Centre Hospitalier de La Côte Basque
        • Contact:
        • Contact:
        • Principal Investigator:
          • Franck AUDEMAR, Dr
      • Beauvais, France, 60021
      • Besançon, France, 25030
        • Not yet recruiting
        • Chu - Hôpital Jean Minjoz
        • Principal Investigator:
          • Stéfano KIM, Dr
        • Contact:
        • Contact:
      • Bordeaux, France, 33076
        • Recruiting
        • Privé - Cac - Clinique Bergonié
        • Contact:
        • Contact:
        • Principal Investigator:
          • Simon PERNOT, Dr
      • Bordeaux, France
      • Bordeaux CEDEX, France, 33077
      • Boulogne, France
      • Boulogne-sur-Mer, France
        • Recruiting
        • Ch - Hôpital Duchenne
        • Contact:
        • Contact:
        • Principal Investigator:
          • Vincent BOURGEOIS, Dr
      • Brest, France, 29609
        • Recruiting
        • Chu - Hôpital Morvan - Institut de Cancérologie
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jean-Philippe METGES, Dr
      • Brest, France
      • Béziers, France
      • Caen, France, 14000
        • Not yet recruiting
        • Privé - Centre Maurice Tubiana
        • Contact:
        • Contact:
        • Principal Investigator:
          • Emmanuel SEVIN, Dr
      • Caen, France, 14076
      • Caen, France
        • Not yet recruiting
        • Prive - Polyclinique Du Parc Caen
        • Contact:
          • Emmanuel SEVIN
          • Phone Number: 0231522000
        • Contact:
          • Khadija JALALI
          • Phone Number: 0231522000
        • Principal Investigator:
          • Emmanuel SEVIN
        • Sub-Investigator:
          • Khadija JALALI
      • Caluire-et-Cuire, France, 69300
      • Challes-les-Eaux, France, 73190
      • Champigny-sur-Marne, France, 94500
        • Recruiting
        • Privé - Hôpital Privé Paul D'Egine
        • Contact:
        • Contact:
        • Principal Investigator:
          • Adil CHAFAI EL ALAOUI, Dr
      • Cholet, France, 49300
        • Recruiting
        • Ch - Centre Hospitalier de Cholet
        • Contact:
        • Contact:
        • Principal Investigator:
          • You-Heng LAM, Dr
      • Clermont Ferrand, France
      • Colmar, France, 68024
      • Compiègne CEDEX, France, 60204
        • Not yet recruiting
        • Privé - Clinique Saint Come
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kaïs ALDABBAGH, Dr
      • Coudekerque-Branche, France, 59210
      • Creil, France, 60100
      • Créteil, France
      • Créteil CEDEX, France, 94000
        • Recruiting
        • Chu - Hôpital Henri Mondor
        • Contact:
        • Contact:
        • Principal Investigator:
          • Isabelle BAUMGAERTNER, Dr
      • Dijon, France, 21079
        • Not yet recruiting
        • Privé - Cac - Centre Georges-Francois Leclerc
        • Contact:
        • Contact:
        • Principal Investigator:
          • François GHIRINGHELLI, Pr
      • Dijon CEDEX, France, 21079
        • Recruiting
        • Chu - Hôpital François Mitterrand
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sylvain MANFREDI, Pr
      • La Chaussee St Victor, France, 41260
        • Recruiting
        • Privé - Polyclinique de Blois - 3Eme Etage
        • Contact:
        • Contact:
        • Principal Investigator:
          • Philippe LAPLAIGE, Dr
      • La Roche-sur-Yon, France, 85925
        • Recruiting
        • Ch - Chd Vendée
        • Contact:
        • Contact:
        • Principal Investigator:
          • Margot LALY, Dr
      • La Rochelle, France
        • Recruiting
        • CH - GROUPE HOSPITALIER DE La Rochelle RE AUNIS
      • Levallois-Perret, France
      • Lille, France
        • Not yet recruiting
        • Privé - Clinique Du Bois
        • Contact:
        • Contact:
        • Principal Investigator:
          • Eric Yaovi Mesan AMELA, Dr
      • Limoges, France, 87042
        • Recruiting
        • Chu - Centre Hospitalier Dupuytren
        • Contact:
        • Contact:
        • Principal Investigator:
          • Valerie LE BRUN LY, Dr
      • Lorient CEDEX, France, 56322
        • Recruiting
        • Ch - Chbs - Hôpital Du Scorff
        • Contact:
        • Contact:
        • Principal Investigator:
          • Joëlle EGRETEAU, Dr
      • Lyon, France, 69008
        • Recruiting
        • Privé - Hôpital Jean Mermoz
        • Contact:
        • Contact:
        • Principal Investigator:
          • Chloé VERNET, Dr
      • Marseille, France, 13008
      • Marseille, France
        • Recruiting
        • Privé - Haliodx
        • Contact:
          • Isabelle BOQUET
        • Contact:
        • Sub-Investigator:
          • Isabelle BOQUET
        • Sub-Investigator:
          • Mélanie GRUBNER
      • Marseille CEDEX 03, France, 13331
      • Marseille CEDEX 5, France, 13385
        • Not yet recruiting
        • Chu - Hôpital La Timone
        • Contact:
        • Contact:
        • Principal Investigator:
          • Laétitia DAHAN, Pr
      • Meaux, France, 77100
        • Recruiting
        • Ch - Ghi - Groupe Hospitalier de L'Est Francilien - Site de Meaux
        • Contact:
        • Contact:
        • Principal Investigator:
          • Christophe LOCHER, Dr
      • Mont-de-Marsan, France, 40 000
        • Recruiting
        • Ch - Hôpital Layné
        • Contact:
        • Contact:
        • Principal Investigator:
          • Patrick TEXEREAU, Dr
      • Mougins, France, 06250
        • Recruiting
        • Privé - Centre Azureen de Cancerologie
        • Contact:
        • Contact:
        • Principal Investigator:
          • Benjamin HOCH, Dr
      • Mougins, France, 06250
        • Recruiting
        • Privé - Hôpital Prive Arnault Tzanck
        • Contact:
        • Principal Investigator:
          • Benjamin HOCH, Dr
        • Contact:
      • Nancy, France, 54100
        • Not yet recruiting
        • Privé - Polyclinique de Gentilly
        • Contact:
        • Contact:
        • Principal Investigator:
          • Fabien BROCARD, Dr
      • Nîmes, France, 30029
        • Recruiting
        • Chu - Hôpital Carémeau
        • Contact:
        • Contact:
        • Principal Investigator:
          • Valérie PHOUTTHASANG, Dr
      • Paris, France, 75014
        • Recruiting
        • Privé - Institut Mutualiste Montsouris
        • Contact:
        • Contact:
        • Principal Investigator:
          • Christophe LOUVET, Dr
      • Paris, France, 75015
        • Recruiting
        • Chu - Hôpital Européen Georges Pompidou
        • Contact:
        • Contact:
        • Principal Investigator:
          • Julien TAIEB, Dr
      • Paris, France, 75020
        • Recruiting
        • Privé - Groupe Hospitalier Diaconesses Croix Saint Simon
        • Contact:
        • Contact:
        • Principal Investigator:
          • Olivier DUBREUIL, Dr
      • Paris, France
        • Not yet recruiting
        • Chu - Hôpital Saint Antoine
      • Paris, France
        • Not yet recruiting
        • Chu - Hôpital Saint-Louis
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Jean-Marc GORNET
        • Principal Investigator:
          • Thomas APARICIO, Pr
      • Pau CEDEX, France, 64046
        • Recruiting
        • CH - Centre Hospitalier de Pau
        • Contact:
        • Contact:
        • Principal Investigator:
          • Juliette THAURY, Dr
      • Perigueux, France, 24004
        • Recruiting
        • Privé - Polyclinique Francheville
        • Contact:
        • Contact:
        • Principal Investigator:
          • Laurent CANY
      • Perpignan, France
      • Pessac, France
        • Not yet recruiting
        • Chu - Hôpital Haut Lévêque
        • Principal Investigator:
          • Denis Smith
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Eric TERREBONNE
      • Pierre-Bénite, France, 69495
        • Recruiting
        • Chu Lyon Sud - Pierre Benite
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marion CHAUVENET, Dr
      • Plérin, France
        • Recruiting
        • Privé - Centre Cario Hpca
      • Poitiers, France, 86021
        • Recruiting
        • Chu - Centre Hospitalier Universitaire de Poitiers - La Miletrie
        • Contact:
        • Contact:
        • Principal Investigator:
          • David TOUGERON, Pr
      • Quimper, France
      • Reims, France, 51726
      • Reims CEDEX, France, 51092
        • Recruiting
        • Chu - Centre Hospitalier Universitaire Robert Debre
        • Contact:
        • Contact:
        • Principal Investigator:
          • Olivier BOUCHE, Pr
      • Rennes CEDEX 9, France, 35033
        • Recruiting
        • Chu - Centre Hospitalier Universitaire Pontchaillou
        • Principal Investigator:
          • Astrid Lievre, Pr
        • Contact:
      • Romans-sur-Isère, France, 26100
        • Recruiting
        • Ch - Hôpital Drome Nord
        • Contact:
        • Principal Investigator:
          • Marie-Claude GOUTTEBEL, Dr
      • Saint-Grégoire, France
      • Saint-Herblain, France, 44805
      • Saint-Malo, France, 35403
        • Recruiting
        • Ch - Centre Hospitalier de Saint-Malo
        • Contact:
        • Contact:
        • Principal Investigator:
          • Anaïs BODERE, Dr
      • Saint-Priest-en-Jarez, France, 42270
        • Recruiting
        • Chu - Centre Hospitalier Universitaire de Saint Etienne - Hôpital Nord - Service Hge
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jean-Marc PHELIP, Pr
      • Saint-Quentin, France, 02100
        • Not yet recruiting
        • Privé - Polyclinique Saint-Claude
        • Contact:
        • Contact:
        • Principal Investigator:
          • Pierre VANELSLANDER, Dr
      • Sainte-Foy-lès-Lyon, France, 69510
        • Not yet recruiting
        • Privé - Clinique Charcot
        • Contact:
        • Contact:
        • Principal Investigator:
          • Clémence THEVENET, Dr
      • Strasbourg, France, 67000
        • Recruiting
        • Privé - Clinique Sainte Anne
        • Contact:
        • Contact:
        • Principal Investigator:
          • Louis-Marie DOURTHE, Dr
      • Strasbourg, France, 67065
        • Recruiting
        • Privé - Cac - Paul Strauss / Institut de Cancérologie de Strasbourg Europe
        • Contact:
        • Contact:
        • Principal Investigator:
          • Meher BEN ABDELGHANI, Dr
      • Suresnes, France, 92151
        • Not yet recruiting
        • Chu - Hôpital Foch
        • Contact:
        • Contact:
        • Principal Investigator:
          • May MABRO, Dr
      • Tarbes, France, 65000
      • Toulon, France, 83000
      • Tours CEDEX 9, France, 37044
        • Recruiting
        • Chu - Hôpital Trousseau
        • Contact:
        • Contact:
        • Principal Investigator:
          • Thierry LECOMTE, Pr
      • Valenciennes, France, 59300
        • Not yet recruiting
        • Ch - Centre Hospitalier de Valenciennes
        • Contact:
        • Contact:
        • Principal Investigator:
          • Eduardo BARRASCOUT, Dr
      • Vandœuvre-lès-Nancy, France, 54519
        • Recruiting
        • Privé - Cac - Institut de Cancerologie de Lorraine
        • Contact:
        • Contact:
        • Principal Investigator:
          • Pierre LEHAIR, Dr
      • Vandœuvre-lès-Nancy, France
        • Recruiting
        • Chu - Hôpital Bradois
        • Contact:
        • Contact:
        • Principal Investigator:
          • Anthony LOPEZ, Dr
      • Villejuif, France, 94804
        • Not yet recruiting
        • Chu - Hôpital Paul Brousse
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ayhan ULUSAKARYA, Dr
      • Villejuif, France
        • Recruiting
        • Privé - Cac - Institut Gustave Roussy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • MSS and pMMR metastatic colorectal adenocarcinoma (metachronous or synchronous metastases), histologically proven
  • Patients who have had chemotherapy (neo-adjuvant or adjuvant) or radiotherapy (neo-adjuvant or adjuvant) for the treatment of primary tumor or metastatic resected disease R0 can be included if they have a recurrence more than 6 months after the end of this treatment.
  • High immune response defined as the immune infiltration scores obtained on the primary tumour (resection of primary tumour containing at least 2 mm of tumour-free margin between the tumour and non-tumour area)
  • Unresectable cancer with at least one measurable metastatic target according to RECIST v1.1 criteria
  • WHO PS ≤ 1
  • Life expectancy ≥ 3 months
  • Adequate haematological function: neutrophils ≥ 1,500 /mm3, platelets ≥ 100,000/mm3, Hb > 9 g/dL
  • Adequate liver function: AST/ALT ≤ 5xULN, total bilirubin ≤ 2xULN, alkaline phosphatase. ≤ 5xULN
  • Creatinine clearance > 50 mL/min according to the MDRD formula
  • Proteinuria <2+ (dipstick urinalysis) or ≤1g/24hour
  • Patient who is a beneficiary of the social security system
  • Information provided to patient and signature of the informed consent form

Exclusion Criteria:

  • Active infection requiring intravenous antibiotics at day 1 of cycle 1
  • Active or untreated central nervous system metastases
  • Another concomitant cancer or history of cancer during the last 5 years, except for carcinoma in situ of the uterine cervix or a basal cell or squamous cell skin carcinoma or any other carcinoma in situ considered as cured
  • Previous bone marrow allogenic stem cell transplantation or previous organ transplantation
  • History of idiopathic pulmonary fibrosis, medicinal product-related pneumonia or proof of active pneumonia or pneumonitis on a chest CT-scan prior to therapy
  • HIV infection, active hepatitis B or C infection, active tuberculosis
  • Colorectal cancer with microsatellite instability (dMMR and/or MSI)
  • Patient eligible for curative treatment (resection and/or thermal ablation according to the opinion of the local multidisciplinary tumour meeting board)
  • Patient with only primary tumour biopsies available or only a sample of a metastasis (no surgical resection of the primary tumour)
  • Previous treatment with anti-PD1 or anti-PDL1 or another immunotherapy
  • An auto-immune disease which may worsen during treatment with an immune-stimulating agent (patients with type I diabetes, vitiligo, psoriasis, hypo or hyperthyroidism not requiring immunosuppressant therapy are eligible)
  • Long-term immunosuppressant therapy (patients requiring corticosteroid therapy are eligible if administration at a dose ≤ 10 mg prednisone equivalent dose per day, administration of steroids by a route of administration resulting in minimal systemic exposure (cutaneous, rectal, ocular or inhalation) is authorised)
  • Known severe hypersensitivity to monoclonal antibodies, to one of the medicinal products used or to one of the excipients in the products used or a history of anaphylactic shock or of uncontrolled asthma
  • Vaccinations (live vaccine) within 30 days prior to start of treatment
  • Dihydropyrimidine Dehydrogenase (DPD) deficiency defined by uracilemy level ≥ 16 ng/mL
  • QT/QTc interval > 450 msec in men and > 470 msec in women
  • One of the following disorders during the 6 months prior to inclusion: myocardial infarction, unstable/severe angina pectoris, coronary artery bypass grafting, NYHA class II, III or IV congestive heart failure, stroke or transient ischaemic attack
  • All uncontrolled progressive disorders during the last 6 months: hepatic insufficiency, renal insufficiency, respiratory insufficiency, arterial hypertension
  • History of an inflammatory digestive disease, obstruction or sub-obstruction not resolved with symptomatic treatment
  • Peptic ulcer disease not healed before the treatment
  • Not controlled HTA
  • Patient already enrolled in another therapeutic trial with an ongoing investigational drug or whose treatment ended less than 4 weeks before inclusion
  • Absence of effective contraception in patients (male and/or female patients) of childbearing potential, a pregnant or breastfeeding woman, women of childbearing potential and who have not had a pregnancy test
  • Impossibility to submit to medical follow-up of the trial due to geographic, social or psychological reasons

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immunotherapy + chemotherapy
Xelox bevacizumab plus pembrolizumab every 3 weeks up until disease progression, unacceptable toxicity, refusal by the patient, withdrawal of consent, pregnancy or decision by the investigator.
Drug: Capecitabine
2000 mg/m²/day, from day 1 to 14 of each cycle
Drug: Oxaliplatin
130 mg/m² by IV infusion over 2 hours, on day 1 of each cycle
Drug: Bevacizumab
7.5 mg/kg by IV infusion over 60 minutes, on day 1 of each cycle
Drug: Pembrolizumab
200 mg by IV infusion over 30 minutes, on day 1 of each cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The rate of patients alive and without progression at 10 months after inclusion
Time Frame: 10 months after inclusion
Progression is evaluated by CT scan, according to RECIST criteria (version 1.1) definition by the investigator. Death was also considered as an event (all causes). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions compared the little sum of diameters observed during the study (NADIR), or a measurable increase in a non-target lesion, or the appearance of new lesions
10 months after inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: Up to 2 years after the end of the treatment
Overall survival is defined as the time from the date of the patient's inclusion to the patient's death (all causes). For alive patients the date of the latest news is taken into account
Up to 2 years after the end of the treatment
Histological response in case of secondary resection
Time Frame: Up to 2 years after the end of the treatment
Response evaluated according to the TRG (Rubbia-Brandt L et al. Annals Oncol 2007), for patients who underwent a secondary resection
Up to 2 years after the end of the treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federation Francophone de Cancerologie Digestive

Investigators

  • Principal Investigator: David TOUGERON, MD,PHD, CHU Poitiers

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 6, 2021

Primary Completion (Estimated)

September 30, 2024

Study Completion (Estimated)

September 30, 2024

Study Registration Dates

First Submitted

February 6, 2020

First Submitted That Met QC Criteria

February 7, 2020

First Posted (Actual)

February 10, 2020

Study Record Updates

Last Update Posted (Actual)

August 18, 2023

Last Update Submitted That Met QC Criteria

August 16, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FFCD 1703 POCHI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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